VIALPROTECTION AGE DEFYING PROTECTIVE SPF 50- homosalate, octisalate, avobenzone oxybenzone lotion 
DARPHIN DIST.

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.

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ACTIVE INGREDIENTS: HOMOSALATE 5.00% [] OCTISALATE 5.00% [] AVOBENZONE 3.00% [] OXYBENZONE 3.00%

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

WARNING: FOR EXTERNAL USE ONLY. KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.STOP USE AND ASK A DOCTOR STOP USE IF IRRITATION OR IRRITATION DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP RIGHT AWAY

PRINCIPAL DISPLAY PANEL

DARPHIN

VITALPROTECTION

AGE DEFYING

PROTECTIVE LOTION

SPF 50





1.6 FL OZ. LIQ/50 ML



DARPHIN DISTR.

PARIS, FRANCE


FOLDING CARTON


VIALPROTECTION  AGE DEFYING PROTECTIVE SPF 50
homosalate, octisalate, avobenzone oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16555-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16555-006-011 in 1 CARTON
1NDC:16555-006-0250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2009
Labeler - DARPHIN DIST. (105157494)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture
Establishment
NameAddressID/FEIBusiness Operations
BIOCOSM LABORATORIES288479491manufacture

Revised: 8/2010
Document Id: 0aa154f3-2406-468f-b650-1163e3111890
Set id: 93ca06ec-bc91-4418-9477-7ab9d1c2f578
Version: 1
Effective Time: 20100819
 
DARPHIN DIST.