Label: AVOBENZONE, HOMOSALATE, OCTISALATE lotion
- NDC Code(s): 79481-0954-1
- Packager: Meijer Distribution, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 29, 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 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, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, neopentyl glycol diheptanoate, glyceryl stearate, silica, polyester-7, beeswax, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, potassium hydroxide, chlorphenesin, tocopherol, benzyl alcohol, arachidyl alcohol, fragrance, PEG-100 stearate, behenyl alcohol, arachidyl glucoside, disodium EDTA, amyl cinnamal, sodium ascorbyl phosphate
- SPL UNCLASSIFIED SECTION
- Adverse Reaction
- Principal Panel Display
-
INGREDIENTS AND APPEARANCE
AVOBENZONE, HOMOSALATE, OCTISALATE
avobenzone, homosalate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0954 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 120 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) STYRENE (UNII: 44LJ2U959V) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYESTER-7 (UNII: 0841698D2F) YELLOW WAX (UNII: 2ZA36H0S2V) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CHLORPHENESIN (UNII: I670DAL4SZ) TOCOPHEROL (UNII: R0ZB2556P8) BENZYL ALCOHOL (UNII: LKG8494WBH) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0954-1 89 mL in 1 TUBE; Type 0: Not a Combination Product 08/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/28/2023 Labeler - Meijer Distribution, Inc (006959555) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(79481-0954)
