Label: AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE lotion
- NDC Code(s): 79481-9402-1
- Packager: Meijer Distribution
- 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 June 5, 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.
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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, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, fragrance, benzyl alcohol, disodium EDTA
- SPL UNCLASSIFIED SECTION
- Principal Panel Display
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INGREDIENTS AND APPEARANCE
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-9402 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 45 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) POLYESTER-7 (UNII: 0841698D2F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) YELLOW WAX (UNII: 2ZA36H0S2V) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) DOCOSANOL (UNII: 9G1OE216XY) TOCOPHEROL (UNII: R0ZB2556P8) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-9402-1 89 mL in 1 TUBE; Type 0: Not a Combination Product 06/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/05/2023 Labeler - Meijer Distribution (006959555) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(79481-9402) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(79481-9402)
