ILLUMINATING PROTECTIVE PRIMER SPF 12

Dosage form: cream
Ingredients: OCTINOXATE 7.5mL in 100mL, HOMOSALATE 5.0mL in 100mL
Labeler: TOM FORD BEAUTY DIST
NDC Code: 76398-001

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.

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

ILLUMINATING PROTECTIVE PRIMER  SPF 12
octinoxate, homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76398-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE5.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
SHEA BUTTER 
PHENYL TRIMETHICONE 
CETOSTEARYL ALCOHOL 
DIMETHICONE 
ALPHA-TOCOPHEROL ACETATE 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
EPILOBIUM ANGUSTIFOLIUM LEAF 
VANILLA 
DIPTERYX ODORATA SEED 
SAPINDUS MUKOROSSI FRUIT 
COCONUT OIL 
PATCHOULI OIL 
CANANGA OIL 
AMYRIS BALSAMIFERA OIL 
VETIVER OIL 
BERGAMOT OIL 
EVENING PRIMROSE OIL 
LECITHIN, SOYBEAN 
CAFFEINE 
CAESALPINIA SPINOSA RESIN 
PROPYLENE GLYCOL LAURATES 
SQUALANE 
SORBITAN MONOSTEARATE 
PEG-40 STEARATE 
ETHYLHEXYLGLYCERIN 
BUTYLENE GLYCOL 
DIHEXADECYL PHOSPHATE 
CETETH-10 PHOSPHATE 
XANTHAN GUM 
POLYSORBATE 60 
HYALURONATE SODIUM 
SORBITAN MONOLAURATE 
POTASSIUM SORBATE 
POLYSORBATE 20 
CITRIC ACID MONOHYDRATE 
STANNIC OXIDE 
EDETATE SODIUM 
CHLORPHENESIN 
PHENOXYETHANOL 
TITANIUM DIOXIDE 
MICA 
Packaging
#Item CodePackage Description
1NDC:76398-001-011 BOTTLE (BOTTLE) 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/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 10/2011
 
TOM FORD BEAUTY DIST

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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