Label: SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 72288-914-21
- Packager: Amazon.com Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 10, 2024
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- Official Label (Printer Friendly)
- active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
■ apply liberally {and evenly} 15 minutes before sun exposure
■ apply to all skin exposed to the sun
■ reapply:
■ after 80 minutes of swimming or sweating
■ immediately after towel drying
■ at least every 2 hours
■ 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 a.m.–2 p.m.
■ wear long-sleeved shirts, pants, hats and sunglasses
■ children under 6 months of age: Ask a doctor - Other information
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inactive ingredients
water, silica, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, glyceryl stearate, PEG-100 stearate, caprylyl methicone, cetyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, glycerin, pentylene glycol, acrylates/C12-22 alkyl methacrylate copolymer, ethylhexyl stearate, chlorphenesin, disodium EDTA, fragrance, diethylhexyl 2,6-naphthalate, BHT, trideceth-6
- SPL UNCLASSIFIED SECTION
- Principal display panel
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INGREDIENTS AND APPEARANCE
SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-914 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) BENZYL ALCOHOL (UNII: LKG8494WBH) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) DOCOSANOL (UNII: 9G1OE216XY) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) ALLYL METHACRYLATE (UNII: G2IG50653Z) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TRIDECETH-6 (UNII: 3T5PCR2H0C) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-914-21 89 mL in 1 TUBE; Type 0: Not a Combination Product 09/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/08/2019 Labeler - Amazon.com Services LLC (128990418) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(72288-914)
