Label: ANEW REVERSALIST DAY RENEWAL- octinoxate, octisalate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0181-1, 10096-0181-2, 10096-0181-3, 10096-0181-4, view more10096-0181-5, 10096-0181-6, 10096-0181-7 - Packager: Avon Products, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 4, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
• apply liberally 15 minutes before sun exposure
• children under 6 months of age: ask a doctor
• 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 - STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients: WATER/EAU, DIMETHICONE, GLYCERIN, BUTYLENE GLYCOL,
ISODECYL ISONONANOATE, TROMETHAMINE, DILAURYL THIODIPROPIONATE, PHYTOL,
THIODIPROPIONIC ACID, THIAZOLYLALANINE, SESBANIA GRANDIFLORA FLOWER EXTRACT,
AMORPHOPHALLUS CAMPANULATUS RHIZOME/ROOT EXTRACT, PUNICA GRANATUM FRUIT
JUICE, PALMITOYL LYSYL AMINOVALEROYL LYSINE, TOCOPHEROL, POLYSORBATE 20,
CETEARYL ALCOHOL, KAEMPFERIA GALANGA ROOT EXTRACT, ISOHEXADECANE,
CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, NYLON-12,
POLYMETHYLSILSESQUIOXANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL
TAURATE COPOLYMER, XANTHAN GUM, CETEARETH-20, HYDROGENATED LECITHIN, SILICA,
POLYSORBATE 60, TRIMETHYLSILOXYSILICATE, SORBITAN ISOSTEARATE, DIMETHICONE
CROSSPOLYMER, POLYMETHYL METHACRYLATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA,
PHENOXYETHANOL, PARFUM/FRAGRANCE. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANEW REVERSALIST DAY RENEWAL
octinoxate, octisalate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0181 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 71.1 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 47.5 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40.0 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28.5 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0181-2 1 in 1 CARTON 1 NDC:10096-0181-1 50 g in 1 JAR 2 NDC:10096-0181-4 1 in 1 CARTON 2 NDC:10096-0181-3 15 g in 1 JAR 3 NDC:10096-0181-6 1 in 1 CARTON 3 NDC:10096-0181-5 7 g in 1 JAR 4 NDC:10096-0181-7 1.1 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/15/2009 Labeler - Avon Products, Inc (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc 005149471 manufacture(10096-0181)
