YOUTH FULL TINTED MOISTURIZER SPF 15- octinoxate, titanium dioxide liquid 
AMERICAN BEAUTY COSMETICS

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: OCTINOXATE 7.50% [] TITANIUM DIOXIDE 3.00%

INGREDIENTS: WATER [] PHENYL TRIMETHICONE [] BUTYLENE GLYCOL [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] PETROLATUM [] BIOSACCHARIDE GUM - 1 [] STEARETH-21 [] GLYCERYL STEARATE [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] POLYMETHYL METHACRYLATE [] MAGNESIUM ALUMINUM SILICATE [] ETHYLHEXYLGLYCERIN [] CAPRYLYL GLYCOL [] CETYL ALCOHOL [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] PEG-12 DIMETHICONE [] ISOHEXADECANE [] LECITHIN [] ALUMINA [] XANTHAN GUM [] STEARETH-2 [] POTASSIUM STEARATE [] CITRIC ACID [] FRAGRANCE (PARFUM) [] LIMONENE [] LINALOOL [] BENZYL SALICYLATE [] POLYSORBATE 80 [] DISODIUM EDTA [] PHENOXYETHANOL [] SORBIC ACID []  [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN


PRINCIPAL DISPLAY PANEL:

AMERICAN
BEAUTY

YOUTH-FULL

SHEER COLOR

TINTED MOISTURIZER

 SPF 15

NT WT 1.7 OZ./ 50 ML






AMERICAN BEAUTY COSMETICS, DIST
NEW YORK, NY 10022

FOLDING CARTON

YOUTH FULL TINTED MOISTURIZER  SPF 15
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68759-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
JOJOBA OIL (UNII: 724GKU717M)  
PETROLATUM (UNII: 4T6H12BN9U)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
STEARETH-21 (UNII: 53J3F32P58)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARETH-2 (UNII: V56DFE46J5)  
POTASSIUM STEARATE (UNII: 17V812XK50)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBIC ACID (UNII: X045WJ989B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68759-003-011 in 1 CARTON
1NDC:68759-003-0250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2010
Labeler - AMERICAN BEAUTY COSMETICS (143367634)
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

Revised: 7/2011
Document Id: d0b487ac-4e50-45d1-b5ae-844b65e3c8af
Set id: 74d28465-56a5-49c6-a49a-1ea42f4addf3
Version: 1
Effective Time: 20110707
 
AMERICAN BEAUTY COSMETICS