Label: PROTECTION 50 SPORT- homosalate, octocrylene, octisalate, and avobenzone lotion
- NDC Code(s): 68479-232-00, 68479-232-02
- Packager: Dermalogica, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 July 8, 2022
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- Download DRUG LABEL INFO: PDF XML
- 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), helps decrease the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply:
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- after 80 minutes of swimming or sweating.
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- immediately after towel drying.
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- at least every 2 hours.
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
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- limit time in the sun, especially from 10 a.m. – 2 p.m.
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- wear long-sleeve shirts, pants, hats and sunglasses.
- Children under 6 months: ask a doctor.
- Other information
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Inactive ingredients
Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, Dimethicone, Methyl Methacrylate Crosspolymer, C15-19 Alkane, VP/ Eicosene Copolymer, Silica, Dimethyl Capramide, Polyglyceryl-2 Stearate, Squalane, Dipotassium Glycyrrhizate, Arachidyl Glucoside, Glyceryl Stearate SE, PEG-100 Stearate, Arachidyl Alcohol, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Behenyl Alcohol, Xanthan Gum, Acrylates/C10- 30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Citric Acid, Phenoxyethanol.
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 156 mL Tube Carton
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INGREDIENTS AND APPEARANCE
PROTECTION 50 SPORT
homosalate, octocrylene, octisalate, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-232 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 10 mg in 100 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 10 mg in 100 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5 mg in 100 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 mg in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) SAFFLOWER OIL (UNII: 65UEH262IS) Dimethicone (UNII: 92RU3N3Y1O) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) C15-19 Alkane (UNII: CI87N1IM01) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Dimethyl Capramide (UNII: O29Y6X2JEZ) Polyglyceryl-2 Stearate (UNII: 253MC0P0YV) Phenoxyethanol (UNII: HIE492ZZ3T) PEG-100 Stearate (UNII: YD01N1999R) Glyceryl Stearate SE (UNII: FCZ5MH785I) Arachidyl Alcohol (UNII: 1QR1QRA9BU) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Squalane (UNII: GW89575KF9) DOCOSANOL (UNII: 9G1OE216XY) Xanthan Gum (UNII: TTV12P4NEE) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Benzyl Alcohol (UNII: LKG8494WBH) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) Ethylhexylglycerin (UNII: 147D247K3P) Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY) Sodium Hydroxide (UNII: 55X04QC32I) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-232-02 1 in 1 CARTON 08/05/2019 1 156 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68479-232-00 2 mL in 1 POUCH; Type 0: Not a Combination Product 08/05/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/05/2019 Labeler - Dermalogica, LLC. (177698560) Establishment Name Address ID/FEI Business Operations Cosway 052400223 MANUFACTURE(68479-232)