SUN PREMIUM FACE 50 SPF - oxybenzone, octinoxate, avobenzone, titanium dioxide cream 
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA

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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SUN PREMIUM FACE 50+ SPF

ATACHE

SCIENTIFIC COSMETIC

SUN PREMIUM


FACE
50+ SPF
UVA-UVB

VERY
HIGH

COLOR

ANTIAGE PROTECTIVE FACE CREAM
WITH COLOR

75 ml e  2.53 FL OZ

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:  Apply evenly to the face and neck half an hour before sunbathing.  Apply again each 1-2 hours or after bathing.

WARNINGS:   For external use only.  Keep out of reach of children.  Avoid contact with eyes.  Discontinue use if signs of irritation of rash appear.

ACTIVE INGREDIENTS:

OXYBENZONE 5% - sunscreen

OCTINOXATE 5% - sunscreen

AVOBENZONE 2% - sunscreen

TITANIUM DIOXIDE 1.5% - sunscreen



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.


Image of CartonEnter section text here

SUN PREMIUM FACE 50 SPF 
oxybenzone, octinoxate, avobenzone, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.75 mL  in 75 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 75 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mL  in 75 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.185 mL  in 75 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75870-006-021 in 1 CARTON
1NDC:75870-006-0175 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/15/2007
Labeler - LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA (467582193)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA467582193manufacture

Revised: 6/2011
Document Id: c2955e48-40cc-433b-ba15-3228a0c6fdc9
Set id: 623c3609-8597-4382-b791-0bbb4ca1cfaf
Version: 2
Effective Time: 20110616
 
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA