Label: SUN PREMIUM FACE 50 SPF- oxybenzone, octinoxate, avobenzone, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75870-006-01, 75870-006-02 - Packager: LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA
- Category: HUMAN OTC DRUG LABEL
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 June 16, 2011
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DESCRIPTION
ANTIAGE PROTECTIVE FACE CREAM
WITH COLOR
Innovative combination of a selection of extracts that offer a perfect balance between sun protection and beauty. A soft, pleasant texture on your skin, that lets you enjoy an even tan while it protects your face from the signs of ageing and gives a firmer appearance.
- INSTRUCTIONS FOR USE
- WARNINGS
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
OTHER INGREDIENTS: AQUA (WATER), ALOE VERA GEL, UREA, CETEARYL ALCOHOL, GLLYCERIN, C12-20 ALKYL BENZOATE, ISOHEXADECANE, TRIETHYLEXANOIN, CETYL PALMITATE, DIMETHICONE, TRIMETHOXYCAPRYLYLSILANE, STEARETH-2, BUTYROSPERMUM PARK II (SHEA BUTTER), PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, CYCLOMETHICONE, DIMETHICONOL, CETETH-25, PEG-0 STEARATE, BEHENYL ALCOHOL, SODIUM PCA, GLYCERETH-26, STEARETH-21, SQUALANE, PARAFFIN, DIAZOLIDINYL UREA, ECHINACEA ANTUSTIFOLIA EXTRACT, CENTELLA ASIATICA EXTRACT, FUCUS VESICULOSUS EXTRACT, TRIGONELLA FOENUM-GRAECUM SEED EXTRACT, PROPYLENE GLYCOL, PEG-20 CASTOR OIL, ALCOHOL DENAT, PEG-60 HYDROGENATED CASTOR OIL, CALCIUM PANTOTHENATE, INOSITOL, BIOTIN, RETINOL, TOCOPHERYL ACETATE, GLYCERYL LINOLEATE, GLYCERYL LINOLENATE, GLYCERYL ARACHIDONATE, ALUMINIUM STEARATE, ALUMINA, XANTHAN GUM, ALLANTOIN, COCOS NUCIFERA (COCONUM OIL), GARDENIA TAHITENSIS (TIARE FLOWER), PARFUM (FRAGRANCE), LIMONENE, LINALOOL, TETRASODIUM EDTA, POLYHYDROXYESTEARIC ACID, TOCOPHERYL ACETATE, DIPALMITOYL HYDROXYPROLINE.
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INGREDIENTS AND APPEARANCE
SUN PREMIUM FACE 50 SPF
oxybenzone, octinoxate, avobenzone, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75870-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.75 mL in 75 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.75 mL in 75 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 mL in 75 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 1.185 mL in 75 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) UREA (UNII: 8W8T17847W) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C) ISOHEXADECANE (UNII: 918X1OUF1E) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) CETYL PALMITATE (UNII: 5ZA2S6B08X) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) STEARETH-2 (UNII: V56DFE46J5) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CYCLOMETHICONE (UNII: NMQ347994Z) CETETH-25 (UNII: 5KLY4IOG20) PEG-9 STEARATE (UNII: WZU67V0H4I) DOCOSANOL (UNII: 9G1OE216XY) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) GLYCERETH-26 (UNII: NNE56F2N14) STEARETH-21 (UNII: 53J3F32P58) SQUALANE (UNII: GW89575KF9) PARAFFIN (UNII: I9O0E3H2ZE) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) CENTELLA ASIATICA (UNII: 7M867G6T1U) FUCUS VESICULOSUS (UNII: 535G2ABX9M) FENUGREEK SEED (UNII: 654825W09Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CASTOR OIL (UNII: D5340Y2I9G) ALCOHOL (UNII: 3K9958V90M) POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) INOSITOL (UNII: 4L6452S749) BIOTIN (UNII: 6SO6U10H04) RETINOL (UNII: G2SH0XKK91) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) GLYCERYL LINOLEATE (UNII: 4763AXI84L) GLYCERYL LINOLENATE (UNII: SGB6X4G86K) GLYCERYL ARACHIDONATE (UNII: I4WS2B978B) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ALUMINUM OXIDE (UNII: LMI26O6933) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) COCONUT OIL (UNII: Q9L0O73W7L) GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, DL- (UNII: D81QY6I88E) EDETATE SODIUM (UNII: MP1J8420LU) HYDROXYSTEARIC ACID (UNII: 933ANU3H2S) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75870-006-02 1 in 1 CARTON 1 NDC:75870-006-01 75 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/15/2007 Labeler - LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA (467582193) Establishment Name Address ID/FEI Business Operations LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA 467582193 manufacture
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