SUN PREMIUM FACE 50 SPF- oxybenzone, octinoxate, avobenzone, titanium dioxide cream

SUN PREMIUM FACE 50 SPF by

Drug Labeling and Warnings

SUN PREMIUM FACE 50 SPF by is a Otc medication manufactured, distributed, or labeled by LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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

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

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

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 INGREDIENT

ACTIVE INGREDIENTS:

OXYBENZONE 5% - sunscreen

OCTINOXATE 5% - sunscreen

AVOBENZONE 2% - sunscreen

TITANIUM DIOXIDE 1.5% - sunscreen

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.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

SUN PREMIUM FACE 50 SPF 
oxybenzone, octinoxate, avobenzone, titanium dioxide cream

Product 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