Label: ANEW CLINICAL ABSOLUTE EVEN SPOT CORRECTING HAND- octinoxate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0290-1, 10096-0290-2 - Packager: New Avon LLC
- 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 March 1, 2016
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- 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, PENTAERYTHRITYL TETRAETHYLHEXANOATE, STEARETH-2, GLYCOLIC ACID, BEHENYL ALCOHOL, DIMETHICONE, PEG-40 STEARATE, MYRISTYL MYRISTATE, TRISILOXANE, LAURYL LACTATE, ASPARTIC ACID, ZEA MAYS (CORN) KERNEL EXTRACT, PHYTOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COLA NITIDA SEED EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PUNICA GRANATUM FRUIT JUICE, RETINYL PALMITATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, ASCORBYL PALMITATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, RETINOL, GLYCINE SOJA (SOYBEAN) OIL, SAXIFRAGA SARMENTOSA EXTRACT, VITIS VINIFERA (GRAPE) FRUIT EXTRACT, TOCOPHEROL, BETA-CAROTENE, MORUS NIGRA ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, GLYCERYL STEARATE, PEG-100 STEARATE, PVM/MA DECADIENE CROSSPOLYMER, XANTHAN GUM, SILICA, ACRYLATES/CARBAMATE COPOLYMER, MALTODEXTRIN, LECITHIN, TRIMETHYLSILOXYSILICATE, BUTYLENE GLYCOL, AMMONIUM HYDROXIDE, PHENOXYETHANOL, METHYLPARABEN, DISODIUM EDTA, BHT, PARFUM/FRAGRANCE.
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INGREDIENTS AND APPEARANCE
ANEW CLINICAL ABSOLUTE EVEN SPOT CORRECTING HAND
octinoxate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0290 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) octinoxate 75 mg in 1 g oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) oxybenzone 40 mg in 1 g avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) avobenzone 20 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0290-2 1 in 1 CARTON 1 NDC:10096-0290-1 75 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/11/2012 Labeler - New Avon LLC (080143520) Establishment Name Address ID/FEI Business Operations Avon Products, Inc 005149471 manufacture(10096-0290)