Label: AVOBENZONE, HOMOSALATE, OCTISALATE lotion
- NDC Code(s): 79481-0934-1
- Packager: Meijer, Inc.
- 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 August 7, 2023
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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 liberaly 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especialy 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, styrene/acrylates copolymer, butyloctyl salicylate, silica, glyceryl stearate, PEG-100 stearate, potassium cetyl phosphate, beeswax, behenyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, benzyl alcohol, fragrance, xanthan gum, chlorphenesin, sodium polyacrylate, glycerin, disodium EDTA, BHT, trideceth-6, pentylene glycol
- Disclaimer
- Adverse Reaction
- Principal display panel
-
INGREDIENTS AND APPEARANCE
AVOBENZONE, HOMOSALATE, OCTISALATE
avobenzone, homosalate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0934 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 150 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) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) YELLOW WAX (UNII: 2ZA36H0S2V) DOCOSANOL (UNII: 9G1OE216XY) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) BENZYL ALCOHOL (UNII: LKG8494WBH) XANTHAN GUM (UNII: TTV12P4NEE) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TRIDECETH-6 (UNII: 3T5PCR2H0C) PENTYLENE GLYCOL (UNII: 50C1307PZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0934-1 88 mL in 1 TUBE; Type 0: Not a Combination Product 08/07/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/07/2023 Labeler - Meijer, Inc. (006959555) Registrant - Vi-Jon, LLC (088520668) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(79481-0934) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(79481-0934)
