Label: VIALPROTECTION AGE DEFYING PROTECTIVE SPF 50- homosalate, octisalate, avobenzone oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 16555-006-01, 16555-006-02 - Packager: DARPHIN DIST.
- 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 August 19, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INGREDIENTS: WATER\AQUA\EAU [] BUTYLOCTYL SALICYLATE [] METHYL TRIMETHICONE [] NEOPENTYL GLYCOL DIHEPTANOATE [] POLYESTER-8 [] ALEURITES MOLUCCANA (KUKUI) SEED OIL [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] PEG-100 STEARATE [] BUTYLENE GLYCOL [] GLYCERYL STEARATE [] DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE [] MORUS NIGRA (MULBERRY) ROOT EXTRACT [] SCUTELLARIA BAICALENSIS EXTRACT [] CURCUMA LONGA (TURMERIC) ROOT EXTRACT [] WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT [] LEONTOPODIUM ALPINUM FLOWER EXTRACT [] THERMUS THERMOPHILLUS FERMENT [] VITIS VINIFERA (GRAPE) FRUIT EXTRACT [] LAMINARIA OCHROLEUCA EXTRACT [] PLANKTON EXTRACT [] CAFFEINE [] GLYCERIN [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] POTASSIUM CETYL PHOSPHATE [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] CETYL ALCOHOL [] C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER [] VP/EICOSENE COPOLYMER [] ETHYLHEXYLGLYCERIN [] PALMITIC ACID [] CAPRYLYL GLYCOL [] DEHYDROXANTHAN GUM [] ACETYL GLUCOSAMINE [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] STEARIC ACID [] LECITHIN [] FRAGRANCE (PARFUM) [] LIMONENE [] GERANIOL [] CITRONELLOL [] ALPHA-ISOMETHYL IONONE [] LINALOOL [] BUTYLPHENYL METHYLPROPIONAL [] HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE [] DISODIUM EDTA [] PHENOXYETHANOL [] SODIUM DEHYDROACETATE [] MICA
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VIALPROTECTION AGE DEFYING PROTECTIVE SPF 50
homosalate, octisalate, avobenzone oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16555-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) KUKUI NUT OIL (UNII: TP11QR7B8R) PEG-100 STEARATE (UNII: YD01N1999R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MORUS AUSTRALIS ROOT (UNII: 1VL55O45RF) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) TURMERIC (UNII: 856YO1Z64F) WHEY (UNII: 8617Z5FMF6) LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM) WINE GRAPE (UNII: 3GOV20705G) CAFFEINE (UNII: 3G6A5W338E) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) YEAST (UNII: 3NY3SM6B8U) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PALMITIC ACID (UNII: 2V16EO95H1) CAPRYLYL GLYCOL (UNII: 00YIU5438U) N-ACETYLGLUCOSAMINE (UNII: V956696549) STEARIC ACID (UNII: 4ELV7Z65AP) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16555-006-01 1 in 1 CARTON 1 NDC:16555-006-02 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2009 Labeler - DARPHIN DIST. (105157494) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture Establishment Name Address ID/FEI Business Operations BIOCOSM LABORATORIES 288479491 manufacture
