Label: SOLAR PROTECTION FORMULA SPF 65 SUNSCREEN- octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58892-265-59 - Packager: Fallien Cosmeceuticals, LTD.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 27, 2012
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients:
- Purpose
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Uses:
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings:
- Other Information:
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Directions:
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant product if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months: Ask a doctor
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
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Inactive Ingredients:
Acrylates/Octylacrylamide Copolymer, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, 5-Bromo-5-Nitro-1, 3-Dioxane, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Dimethicone, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Selenium Yeast Extract, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
Solar Protection Formula combines Titanium Dioxide, Zinc Oxide, and Iron Oxide to form a complete wall of reflection against UVA/UVB damage.
Manufactured exclusively for
Fallien Ltd., West Norriton, PA
Made in USA - Principal Display Panel – 2 oz Carton Label
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INGREDIENTS AND APPEARANCE
SOLAR PROTECTION FORMULA SPF 65 SUNSCREEN
octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-265 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 60 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 70 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 40 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 40 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Ascorbyl Palmitate (UNII: QN83US2B0N) 5-Bromo-5-Nitro-1,3-Dioxane (UNII: U184I9QBNM) .Beta.-Carotene (UNII: 01YAE03M7J) Butylparaben (UNII: 3QPI1U3FV8) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cetearyl Glucoside (UNII: 09FUA47KNA) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Ferric Oxide Red (UNII: 1K09F3G675) Isobutylparaben (UNII: 0QQJ25X58G) Isopropylparaben (UNII: A6EOX47QK0) Linoleamidopropyl Dimethylamine (UNII: W142CF4WLF) Octyldodecyl Neopentanoate (UNII: X8725R883T) Phenoxyethanol (UNII: HIE492ZZ3T) Maritime Pine (UNII: 50JZ5Z98QY) Polysorbate 20 (UNII: 7T1F30V5YH) Propylene Glycol (UNII: 6DC9Q167V3) Sorbitan Monolaurate (UNII: 6W9PS8B71J) Talc (UNII: 7SEV7J4R1U) Tocopherol (UNII: R0ZB2556P8) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-265-59 1 in 1 CARTON 1 58.8 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/02/2004 Labeler - Fallien Cosmeceuticals, LTD. (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-265) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging 809172885 MANUFACTURE(58892-265)