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

VIALPROTECTION by

Drug Labeling and Warnings

VIALPROTECTION by is a Otc medication manufactured, distributed, or labeled by DARPHIN DIST., ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation, BIOCOSM LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

DARPHIN

VITALPROTECTION

AGE DEFYING

PROTECTIVE LOTION

SPF 50

1.6 FL OZ. LIQ/50 ML

DARPHIN DISTR.

PARIS, FRANCE

INGREDIENTS AND APPEARANCE

VIALPROTECTION  AGE DEFYING PROTECTIVE SPF 50
homosalate, octisalate, avobenzone oxybenzone lotion

Product 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