Label: ANEW REVERSALIST COMPLETE RENEWAL DAY- homosalate, octinoxate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71110-0010-1 - 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 June 1, 2018
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, glycerin, dimethicone, butylene glycol, isodecyl isononanoate, tromethamine, dilauryl thiodipropionate, phytol, ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetearyl alcohol, nylon-12, polymethylsilsesquioxane, isohexadecane, phenoxyethanol, polymethyl methacrylate, thiodipropionic acid, parfum/fragrance, carbomer, xanthan gum, ceteareth-20, sodium PCA, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, hydrogenated lecithin, kaempferia galanga root extract, silica, polysorbate 60, trimethylsiloxysilicate, dimethicone crosspolymer, thiazolylalanine, amorphophallus campanulatus rhizome/root extract, punica granatum fruit juice, sesbania grandiflora flower extract, portulaca oleracea extract, tocopherol, palmitoyl lysyl aminovaleroyl lysine. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANEW REVERSALIST COMPLETE RENEWAL DAY
homosalate, octinoxate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71110-0010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 70 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28.5 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) THIODIPROPIONIC ACID (UNII: 3BBK323ED8) POLYSORBATE 60 (UNII: CAL22UVI4M) THIAZOLYLALANINE (UNII: VTL1Y3S44B) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) ISODECYL ISONONANOATE (UNII: 4X46Q4U00Z) TROMETHAMINE (UNII: 023C2WHX2V) DILAURYL THIODIPROPIONATE (UNII: V51YH1B080) PHYTOL (UNII: 5BC2RZ81NG) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) NYLON-12 (UNII: 446U8J075B) ISOHEXADECANE (UNII: 918X1OUF1E) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71110-0010-1 1.1 g in 1 PACKET; Type 0: Not a Combination Product 03/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2016 Labeler - Avon Products, Inc. (001468693) Establishment Name Address ID/FEI Business Operations Avon Manufacturing (Guangzhou) Ltd 544863277 manufacture(71110-0010)
