Label: ILLUMINATING PROTECTIVE PRIMER SPF 12- octinoxate, homosalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76398-001-01, 76398-001-02 - Packager: TOM FORD BEAUTY DIST
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 20, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
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]
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ILLUMINATING PROTECTIVE PRIMER SPF 12
octinoxate, homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76398-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76398-001-01 1 in 1 CARTON 1 NDC:76398-001-02 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2009 Labeler - TOM FORD BEAUTY DIST (005914387) 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
