Reef Safe_^TM by Beach Buff_^®

The World’s First Scientifically Substantiated Sun & Skin Care

BIODEGRADABILITY TEST CONCLUSIONS IN SEA & FRESH WATER

If you are serious about protecting our planet’s sensitive ecosystems, ask your current suncare company to prove their “claim” of being “Eco-friendly”, “Biodegradable” and/or “Natural” with scientific test results.   Most likely they don’t have any data since most companies do not scientifically test their products before marketing claims are created. After all there are no regulations on marketing claims, anyone can say their product does just about anything these days. We strive to do better by our customers and our environment, by scientifically proving our claims.

At Tropical Seas_^® we care about your skin protection as well as our environment’s fragile ecosystems.  We scientifically back up our products marketing claims, and have all of our complete assays and test data, including references and protocols on file in our corporate offices. Additionally, we post our scientific test summaries on our web site for our customers benefit.

Once our products have passed The Food & Drug Administration’s standards, we then submit our formulas to an independent ecology laboratory for further testing.  By submitting our formulas for ecology testing, we learn not only their degree of biodegradability, but also their toxicity to sealife. The results below prove that our products biodegrade in oceans, lakes and rivers AND are non-toxic to sealife.

PURPOSE OF STUDY

• Establish scientific data to support  & authenticate Reef Safe Suncare by Beach Buff’s claim utilizing the OECD 306^[1][2] closed-bottle assay for biodegradation in marine environments and OECD 301D^[1][3] for fresh water.

THE EFFECTS OF MASS MARKET AND

OTHER SUNSCREENS ON MARINE LIFE

• The sunscreen that you rub on before a swim in our oceans, lakes and rivers may be protecting your body, but may also be killing marine life. An estimated 4,000 to 6,000 metric tons of sunscreen washes off swimmer’s annually in our oceans worldwide, thus threatening our already fragile ecosystems.^[4]
• Some mass-market sun preparations contain petrolatum, most commonly known as mineral oil, which is derived from dewaxed paraffin-based crude oil,^[5] through processing. Mineral oil has a low solubility rate in water^[5][6] taking years to biodegrade, and is known to be harmful or fatal to aquatic life and waterfowl.^[6] You may have noticed an oil slick that seems to float around you or other people when in the water, this is what happens with some mass-market brands because petroleum-based oils will come off your skin and normally float on the surface of the water. ^[6]
• Many brands on the market today that sell sunscreens with the active ingredient zinc oxide declare their products as being “natural”, but this statement is misleading to consumers. Here’s why: Zinc oxide is not a naturally occurring ore or powder; contrary to what companies claim to consumers, zinc oxide in reality, is an inorganic compound and not of natural origin.^[7][8] Consequently, the ore containing zinc is strip-mined in many countries,^[8][9] devastating the ecosystems surrounding the mines. After the ore has been mined and milled, through crushing and grinding, the ore itself must be concentrated since it is nearly deplete of zinc content. Through the froth flotation process, the zinc ore is ground to a fine powder, then mixed with flotation chemicals and agitated to float to the surface, thus creating the zinc concentrate.^[8][9] This concentrate, which typical contains a percentage of zinc, iron, and sulphur, is then roasted at high temperatures in the presence of oxygen to convert the sulphide to zinc oxide. The impure zinc oxide, called calcine, is then reduced to metallic zinc using heat, electricity and carbon. Finalizing the mineral for approval in USP ^[8][10](United States Pharmaceutical) Grade sunscreens, the processed metallic zinc is melted, boiled and vaporized reacting with oxygen to produce ZnO.^[11]
• Companies say that the zinc oxide in their products will eventually settle to the seafloor and become buried in the sediment, this theory however is poorly understood because the seafloor is ever changing, thus mobilizing and releasing the zinc compounds into our aquatic systems.^[8][12] Though unproven, the zinc may settle onto the seafloor, but until this is scientifically proven, trust the scientific data, which clearly states that zinc oxide is insoluble in water ^{[12][13][14][15][16]} and will never biodegrade; thus continuing to flow through our oceans worldwide. Scientists have also discovered that the free zinc ion is highly toxic to plants, invertebrates, and even vertebrate fish.^[12]
• Another active ingredient being declared “natural” by sunscreen companies is titanium dioxide.  In a process similar to zinc oxide, titanium is strip-mined, concentrated, and then further processed with sulfuric acid or chlorine to produce UPS grade TiO².^[17]
• As with other minerals, titanium dioxide is also insoluble in water and will never biodegrade.^[18]
  

TEST CRITERIA

All testing for Reef Safe Suncare’s waterproofing and biodegradability studies were performed and confirmed by outside Independent Laboratories.

BIODEGRADABILITY TESTING

FOR SEA & FRESH WATER

• Water Sample #1: Collected from the Pacific Ocean at a sandy beach surf zone, near latitude 45.613˚N, longitude 123.943˚W. Sample reflects an environment typically used for recreational purposes, and was not found near any municipal out falls or river mouths, deeming our sample representative of seawater you would want to swim in. This means the test sample contains fewer bacteria that aid in biodegradation than those found near municipal out falls and river mouths.
• Water Sample #2: Collected from the mouth of Yaquina Bay, at a rocky jetty site, near latitude 44.637˚N longitude 124.052˚W, was chosen to reflect a greater loading of microorganisms in seawater due to proximity to Yaquina River and the City of Newport.
• Water Sample #3: Collected from the Columbia River at Rock Creek, Mosier, Oregon, near latitude 45.687260˚N longitude 121.404527˚W, which is a popular freshwater beach site typically used for recreation and other activities. This means the test sample is taken from water you would want to swim in.
• As stated by the Ecology Laboratory summary conclusion, “Average initial degradation rate was 2.7% per day with a plateau at the end of the test period to 1.7% per day”. This means that our products initially started out at 2.7% biodegradability, then gradually slowed down and leveled off at 1.7%.

BIODEGRADABILITY TESTING RESULTS

FOR SEA & FRESH WATER

• Our products biodegrade on average in less than 90 days in seawater & freshwater, based upon the OECD 306^[1][2] and OECD 301D^[1][3] Test methods.
• Products are non-toxic to sealife, as there was no evidence of any toxicity of the product to microorganisms in either sea or fresh water.
• Results may be up to 33% slower in a laboratory testing environment, since actual concentrations of sunblock lotion and the bioavailability of inorganic nutrients would be much lower than in any realistic marine environment; thus making the lab rate slower.
• Conclusion: Based upon laboratory findings, 99% of our Reef Safe suncare products break down in both sea and fresh waters on average in less than 90 days; the remaining 1% is the ash content of the lotion, which is considered non-biodegradeable. This meets the OECD^{[1][2][3][19]} definition of “biodegradeable in sea & fresh water”.
  

WATERPROOF & RUB RESISTANT TESTING

aka VERY WATER RESISTANT

Our SPF’s are layered into a film forming emulsion that provides our products with exceptional waterproofing, otherwise known as very water resistant. By using the static SPF number obtained from Independent Laboratory Testing compared to the 80-minute waterproof SPF number, we established that an average of less than 3% of our product comes off in water during exposure.  Several mass-market brands were plated against Reef Safe by Beach Buff products in our laboratory. First, we recorded a letter on the back of each slide, then we weighed each slide and recorded the weight to three decimal points, and recorded the weight to the corresponding letter in the log book. A thin layer of each product was applied to a lettered glass microscope slide, and then the brand name was recorded into the logbook next to the corresponding letter of each slide.  The slides were then placed in a sealable enclosure called a desiccator for 24 hours; sustaining a state of dryness which, removes all the moisture allowing a film to form on the side. Once the products dried for 24-hours, we equally weighed six beakers of seawater using the three decimal point scale used earlier. After we logged the weight of the dried slides, they were placed in a beaker of room temperature seawater. To simulate movement in the water, we implemented a 3 bladed stainless impeller; a laboratory mixer, which is the standard impeller for many mixing processes due to its efficiency and durability. Each beaker was equipped with a mixer shaft and impeller, and then processed at 400 RPM for exactly 80-minutes. When the timer sounded, the slides were removed from the seawater and allowed to air-dry. Following another 24-hours in the desiccator to remove moisture, the slides were weighed and recorded. After calculating the results, we concluded that compared with Reef Safe suncare products results of less than 3%, up to 29% of mass-market brand lotions come off in water.

To further our analysis, we outsourced an additional independent laboratory to validate the percentage of waterproofing and rub resistance of our products, using protocol: “Final Monograph; “Sunscreen Drug Products For Over-The-Counter Human Use”, Final Rule, 21 CFR Part 352, Subpart D (Federal Register / Vol. 64, No. 98 / Friday May 21, 1999, Proposed Amendment; Docket number 78N-0038/CP12, June 21, 1999). Testing concluded that our sun protection products are on average 97% waterproof after 80 minutes of activity in water, as well as over 100% rub resistant, meaning that when the skin is rubbed by anything including a towel when drying off, the lotion does not come off. We recommend that you apply 20 minutes before sun exposure to allow lotion to absorb into your skin, and then re-apply every 80 minutes to ensure adequate sun protection throughout your time in the sun.

The chart below substantiates our claims and the Independent laboratory testing confirms them.

BIODEGRADABILITY

Our products stay on your skin, not in our oceans; the small percentage that does wash off biodegrades on average in less than 90 days and is non-toxic to sealife. To substantiate these claims, our products were tested in an Independent Ecology Laboratory according to current OECD Protocol 306^[1][2][19] and OECD 301D guidelines.^[1][3][19] In view of the fact that consumers swim in oceans, lakes and rivers and not in sewage water, we opted to distinguish us from the masses, by replacing the industry’s principle test standard of sewage water^[19] with water typical of recreational beaches; thus obtaining a more accurate timeline for biodegradation than if we had just used the principle test standard^[19], which enhances the biodegradation process and as a result, misleads the consumer.

MATHEMATICAL CONCLUSIONS

The FDA states that to evenly cover an average sized adult/child body from head to toe - you would need at least 1 fluid ounce of sunscreen lotion, which is about the amount it takes to fill a shot glass.^[20][21]

Sunscreen Volume Calculation ^[20]

For an average size adult the required volume of sunscreen per application to achieve a 2-mg/cm²-density application is calculated below:

Assuming “average adult”: 5’4” (163cms), 150 lbs (68kgs), 32” waist (82cms)

Whole Body Surface Area = 1.62m² = 16200cm²

Minus "bathing suit” (groin area) 15cms x 82cms= 1219cm^{2 [22]}

Net application area » 14981 cm²

Application Dose = 14981cm² x 0.002g/cm² = 29gms = 1 fl. oz.

The application doses depend on body size and can range from

5’0, 90lb, 30” waist ---> 0.72 fl. oz. / application

6’5” 2251b, 36” waist ---> 1.5 fl oz. / application

Sunscreen products are typically sold in packages of 4 to 8 fl. oz to accommodate multiple applications. As global harmonization of SPF testing has progressed, the 2mg/cm² application amount has become the worldwide standard for SPF testing. 2mg/cm² is not an excessive amount of product; indeed, this application amount is required to adequately and evenly cover the test site for the SPF test. After the product is applied and rubbed in, there is no visible residue on the skin.

Tropical Seas^_® Inc., manufacturer of Reef Safe wanted to know how much of our products would wash off and biodegrade and of that what would be considered non-biodegradeable.  See our results below:

Taking the average of body sizes per the FDA’s recommended dosages above^[20][21] we added the application for a smaller adult of 0.72^[20] fluid ounces to the application for a larger adult of 1.5^[20] fluid ounces, this equals 2.22 fluid ounces.  By halving 2.22 fluid ounces, we achieve an average of 1.11 fluid ounces of sun block needed to cover an average sized adult body.

• Calculation:  0.72 fl. oz + 1.5 fl. oz. = 2.22 fluid ounces
• Calculation: 2.22 fluid ounces ÷ 2 = 1.11 fluid ounces

Next, we converted fluid ounces to grams, as we know there are 29.57 grams to 1 fluid ounce, to determine how many fluid ounces to a gram there are, we multiplied the 1.11 fluid ounce of lotion by 29.57 grams per fluid ounce, which equals 32.8227 grams of sunblock to cover an average sized adult body.

• Calculation:  1.11 fl. oz X 29.57 g = 32.8227 g

Taking our analysis a step further, we determined how many grams of lotion would wash off per person in sea or fresh waters. To do this, we multiplied the 32.8227 grams of sunblock by 3 percent of wash off, which equaled 0.984681 grams total per person that washes off.

• Calculation:  32.8227 g X 3% = 0.984681 g

Our next step was to figure out of the 0.984681 grams, how much would be biodegradeable. We assessed this by multiplying 0.984681 grams of wash off per person by our average rate of biodegradability per OECD^{[1][2][3][19]} testing of 99 percent. This equaled 0.9748341 grams of lotion that biodegrades in oceans, lakes and rivers.

• Calculation: 0.984681 g X 99% = 0.9748341 g

To finalize our calculations, we not only wanted to see how much of our lotion biodegraded, but how much would be considered non-biodegradeable. To do this we took the amount of wash off per person of 0.984681 grams and subtracted it from the biodegraded amount of 0.9748341 grams.  This leaves a net of 0.0098469 grams of non-biodegradeable ash content.

• Calculation:  0.984681 g – 0.9748341 g = 0.0098469 g

Thus, if the estimate of 4,000 to 6,000 metric tons of sunscreen that washes off swimmers annually in our oceans worldwide holds true^[4], than only 120 – 180 metric tons of Reef Safe_^TM Suncare would be washed off.  That being said, if every swimmer switches to Reef Safe, the remaining ash content would be reduced to 1.2 - 1.8 metric tons of non-biodegradeable matter each year. This equates to 3,998.8 – 5,998.2 metric tons less sunscreen chemicals in our oceans annually each year.

REEF SAFE IS BAIT SAFE

PASSES 100MG/LITER LIMIT TEST

Further testing was performed in March 2010, to authenticate Reef Safe Suncare by Beach Buff’s claim that our lotions would not kill baitfish. An independent lab utilized the OECD 203 Acute Toxicity Test^[1][23] to measure the effects on the survival of aquatic organisms in a limit test, wherein if no ill effects occurred at a preselected maximum dose and timeline, than no further testing at a greater exposure level would be required. For analysis, the specific quantity of Reef Safe products were dispensed, and the fatheaded minnows (Pimephales promelas) were observed for 96 hours, during which time the fish exhibited no signs of mortality or abnormality compared to that of the control and exposure tanks. This would be the equivalent of an entire 4 oz. bottle of Reef Safe SPF 45 spilling into a live well, resulting in absolutely no harm to the fish. In conclusion, this limit test greatly exceeds the concentrations anticipated in the environment from casual use and almost certainly that of any accidental spills of Reef Safe Suncare products.

REEF SAFE REEF BABIES & REEF KIDS 

PEDIATRICIAN APPROVED / HYPOALLERGENIC

Testing was performed in May 2010, to scientifically authenticate Reef Safe’s claim that Reef Babies and Reef Kids products are gentle to a child’s sensitive skin.  Tests were supervised, reviewed and approved by a Pediatrician, confirming that both Reef Babies and Reef Kids products are hypoallergenic and safe for sensitive skin.

_{^{1. ^OECD: Guidelines for the testing of chemicals: Organization for Economic Co-operation and Development, Paris.}}

_{^{2. ^OECD (1992), Test No. 306: Biodegradability in Seawater, OECD Guidelines for the Testing of Chemicals, Section 3: Degradation and Accumulation.}}

_{^{3. ^OECD (1992), Test No. 301: Ready Biodegradability Closed Bottle Assay (301 D), OECD Guidelines for the Testing of Chemicals, Section 3: Degradation and Accumulation.}}

_{^{4. ^“Occurrence of UV filter compounds from sunscreens in surface waters: regional mass balance in two Swiss lakes”. Thomas Poiger[a], Hans-Rudolf Buser[a], Marianne E. Balmer[a], Per-Anders Bergqvist[b] and Markus D. Müller[a]. [a]Agroscope, Swiss Federal Research Station for Horticulture, CH-8820, Wädenswil, Switzerland. [b]Institute of Environmental Chemistry, Umeå University, S-90187, Umeå, Sweden. Received 14 July 2003; Revised 22 December 2003; Accepted 15 January 2004. Available online 17 March 2004. Archived from the original on July 3, 2010}}

_{^{5. ^Petroleum High Production Volume (HPV) Testing Group (United States): Test Plan and Robust Summaries Submission for the Waxes and Related Materials Category [Rev: March 27, 2003].}}

_{^{6. ^Material Safety Data Sheet for White Mineral Oil, USP, SKC Inc Revised [March 12, 2009].}}

_{^{8. ^U.S. Department of Health and Human Services, Public Health Service Agency for Toxic Substances and Disease Registry: Toxicology Profile for Zinc. [August 2005].}}

_{^{9. ^U.S Environmental Protection Agency: Compilation of Air Pollutant Emission Factors [1995]. Archived from the original on [June 30, 2010].}}

_{^{10. ^Zinc processing, Encyclopedia Britannica Inc., retrieved 07/02/2010.}}

_{^{11. ^Porter, F. (1991). Zinc Handbook: Properties, Processing, and Use in Design. CRC Press. ISBN 0824783409.}}

_{^{12. ^Contaminant Hazard Reviews (Laurel, Maryland: U.S. Department of the Interior, Fish and Wildlife Service), Eisler, Ronald (1993), "Zinc Hazard to Fish, Wildlife, and Invertebrates: A Synoptic Review".}}

_{^{13. ^Material Safety Data Sheet for Zinc Oxide, USP, Dow Chemical [May 28, 2009].}}

_{^{14. ^Greenwood, Norman N.; Earnshaw, A. (1997), Chemistry of the Elements (2nd ed.), Oxford: Butterworth-Heinemann, ISBN 0080379419.}} 

_{^{15. ^Spero, J. M.; Devito, B.; Theodore, L. (2000). Regulatory chemical handbook. CRC Press. ISBN 0824703901.}}

_{^{16. ^Holleman, Arnold F.; Wiberg, Egon; Wiberg, Nils; (1985), "Zink" (in German), Lehrbuch der Anorganischen Chemie (91–100 ed.), Walter de Gruyter, pp. 1034–1041.}}

_{^{17. ^Stouffer, N., W. Mining For Heavy Minerals. E. I. Du Pont De Nemours & Co., Inc.}}

_{^{18. ^Material Safety Data Sheet for Titanium Dioxide, Metal Oxide, TiO2, USP, Brentag Specialties, Inc. [April 15, 2008].}}

_{^{19. ^OECD (2006), Revised Introduction to the OECD Guidelines for Testing of Chemicals, Section 3, OECD Guidelines for the Testing of Chemicals, Section 3: Degradation and Accumulation, OECD Publishing.}}

_{^{20. ^Food and Drug Administration (United States): “Re: Tentative Final Monograph for OTC Sunscreen”. The Cosmetic, Toiletry, and Fragrance Association (CTFA) and the Nonprescription Drug Manufacturers Association (NINA) and joint Sunscreen Task Force [September 11, 1998].}}

_{^{21. ^Food and Drug Administration (United States): Consumer Updates: “Sun Protection tips” [2010].}}

_{^{22. ^Based on Body Surface Area estimates from: Geigy Scientific Tables. Vol. 3., Medical Education Division, Ciba-Geigy Corp. West Caldwell, NJ. Pg. 329.}}

_{^{23. ^OECD (1992), Test No. 203: Fish, Acute Toxicity Test, OECD Guidelines for the Testing of Chemicals, Section 2: Effects on Biotic Systems.}}