Label: AVON NUTRA EFFECTS BALANCE DAY CREAM- octinoxate, homosalate, avonbenzone, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71110-0015-1 - 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
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
For suncreen use:
Apply liberally and evenly 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-procteion measures, including:
Limite time in the sun, expecially 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, BUTYLENE GLYCOL, DIMETHICONE, ETHYLHEXYL ISONONANOATE, PEG-8, SILICA, GLYCERIN, POLYSILICONE-11, CAPRYLYL GLYCOL, PARFUM/FRAGRANCE, GLYCERYL STEARATE, HYDROGENATED LECITHIN, PHENOXYETHANOL, BEHENYL ALCOHOL, CETYL ALCOHOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, DISODIUM EDTA, PANTHENOL, TALC, CHOLETH-24, ISOHEXADECANE, SODIUM HYDROXIDE, HEXYLENE GLYCOL, CETETH-24, POLYGLYCERYL-3 DIISOSTEARATE, PYRIDOXINE HCL, POLYSORBATE 60, LAURETH-12, TOCOPHERYL ACETATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, PHYTOL, ISOMALT, MALTODEXTRIN, POUZOLZIA PENTANDRA EXTRACT, SALVIA HISPANICA SEED EXTRACT, LECITHIN, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AVON NUTRA EFFECTS BALANCE DAY CREAM
octinoxate, homosalate, avonbenzone, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71110-0015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 55 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 50 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) CETYL ALCOHOL (UNII: 936JST6JCN) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) TALC (UNII: 7SEV7J4R1U) CHOLETH-24 (UNII: 5UE7I54O43) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CETETH-24 (UNII: 0EV3Z43Y2I) POLYSORBATE 60 (UNII: CAL22UVI4M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) PANTHENOL (UNII: WV9CM0O67Z) MALTODEXTRIN (UNII: 7CVR7L4A2D) PHYTOL (UNII: 5BC2RZ81NG) SODIUM HYDROXIDE (UNII: 55X04QC32I) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) ISOMALT (UNII: S870P55O2W) LAURETH-12 (UNII: OAH19558U1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71110-0015-1 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(71110-0015)
