Label: AVOBENZONE, HOMOSALATE, OCTISALATE lotion
- NDC Code(s): 0869-9055-34
- Packager: Vi-Jon, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 1, 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.
-
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
-
Inactive ingredients
water, diethylhexyl 2,6-naphthalate, aluminum starch octenylsuccinate, styrene/acrylates copolymer, butyloctyl salicylate, glyceryl stearate, neopentyl glycol diheptanoate, 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
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- Adverse Reactions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
AVOBENZONE, HOMOSALATE, OCTISALATE
avobenzone, homosalate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-9055 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYESTER-7 (UNII: 0841698D2F) YELLOW WAX (UNII: 2ZA36H0S2V) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CHLORPHENESIN (UNII: I670DAL4SZ) TOCOPHEROL (UNII: R0ZB2556P8) BENZYL ALCOHOL (UNII: LKG8494WBH) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) PEG-100 STEARATE (UNII: YD01N1999R) DOCOSANOL (UNII: 9G1OE216XY) 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:0869-9055-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/03/2023 Labeler - Vi-Jon, LLC (088520668) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(0869-9055)
