ILLUMINATING PROTECTIVE PRIMER SPF 12- octinoxate, homosalate cream 
TOM FORD BEAUTY 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: OCTINOXATE 7.50% [] HOMOSALATE 5.00%

INGREDIENTS: WATER\AQUA\EAU [] PEG-4 DIHEPTANOATE [] GLYCERIN [] BIS-DIGLYCERYL POLYACYLADIPATE-2 [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PHENYL TRIMETHICONE [] POLYETHYLENE [] CETEARYL ALCOHOL [] DIMETHICONE [] TOCOPHERYL ACETATE [] CETYL ALCOHOL [] GLYCERYL STEARATE [] EPILOBIUM ANGUSTIFOLIUM EXTRACT [] VANILLA PLANIFOLIA FRUIT EXTRACT [] DIPTERYX ODORATA SEED EXTRACT [] SAPINDUS MUKUROSSI FRUIT EXTRACT [] MORINDA CITRIFOLIA FRUIT EXTRACT [] COCOS NUCIFERA (COCONUT) OIL [] POGOSTEMON CABLIN (PATCHOULI) OIL [] CANANGA ODORATA FLOWER OIL [] AMYRIS BALSAMIFERA BARK OIL [] VETIVERIA ZIZANOIDES ROOT OIL [] CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL [] OENOTHERA BIENNIS (EVENING PRIMROSE) OIL [] LECITHIN [] CAFFEINE [] CAESALPINIA SPINOSA GUM [] PROPYLENE GLYCOL LAURATE [] SQUALANE [] SORBITAN STEARATE [] PEG-40 STEARATE [] HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER [] ETHYLHEXYLGLYCERIN [] BUTYLENE GLYCOL [] DICETYL PHOSPHATE [] CETETH-10 PHOSPHATE [] XANTHAN GUM [] POLYSORBATE 60 [] PROPYLENE GLYCOL STEARATE [] SODIUM HYALURONATE [] SORBITAN LAURATE [] POTASSIUM SORBATE [] POLYSORBATE 20 [] CITRIC ACID [] TIN OXIDE [] TETRASODIUM EDTA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] LINALOOL [] LIMONENE [] CHLORPHENESIN [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] MICA]

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

PRINCIPAL DISPLAY PANEL:

       TF

TOM FORD



ILLUMINATING PROTECTIVE PRIMER SPF 12



1 OZ./FL.OZ./30 ML



TOM FORD BEAUTY DIST

NEW YORK, NY 10022

FOLDING CARTON

ILLUMINATING PROTECTIVE PRIMER  SPF 12
octinoxate, homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76398-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
VANILLA (UNII: Q74T35078H)  
DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)  
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PATCHOULI OIL (UNII: F3IN55X5PO)  
CANANGA OIL (UNII: 8YOY78GNNX)  
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
VETIVER OIL (UNII: 9M9P32M01L)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CAFFEINE (UNII: 3G6A5W338E)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)  
SQUALANE (UNII: GW89575KF9)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76398-001-011 in 1 CARTON
1NDC:76398-001-0230 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2009
Labeler - TOM FORD BEAUTY DIST (005914387)
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: 10/2011
Document Id: c08ab60d-9dea-4c24-9951-3baf4a1da91b
Set id: 96b3109c-0f1b-48c6-9f97-4e7c621a9060
Version: 1
Effective Time: 20111020
 
TOM FORD BEAUTY DIST