Label: OIL-FREE MOISTURIZER- avobenzone, octisalate, octocrylene lotion
- NDC Code(s): 79481-0238-2
- Packager: Meijer Distribution, 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 December 12, 2022
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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 {and evenly} 15 minutes before sun exposure
■ apply to all skin exposed to the sun
■ reapply at least every 2 hours
■ use a water resistant sunscreen if swimming or sweating
■ 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
- questions
- ADVERSE REACTIONS SECTION
- principal panel display
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INGREDIENTS AND APPEARANCE
OIL-FREE MOISTURIZER
avobenzone, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0238 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 octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) octisalate 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) octyldodecyl neopentanoate (UNII: X8725R883T) glycerin (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 stearate (UNII: YD01N1999R) dimethicone (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) ethylhexylglycerin (UNII: 147D247K3P) caprylyl glycol (UNII: 00YIU5438U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) hydroxyacetophenone (UNII: G1L3HT4CMH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ethylene brassylate (UNII: 9A87HC7ROD) dipropylene glycol (UNII: E107L85C40) 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0238-2 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/15/2020 Labeler - Meijer Distribution, Inc. (006959555) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(79481-0238) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(79481-0238)
