GIORGIO ARMANI FACE FABRIC SECOND SKIN NUDE MAKEUP BROAD SPECTRUM SPF 12 SUNSCREEN- octinoxate lotion

Giorgio Armani Face Fabric Second Skin Nude Makeup Broad Spectrum SPF 12 Sunscreen by

Drug Labeling and Warnings

Giorgio Armani Face Fabric Second Skin Nude Makeup Broad Spectrum SPF 12 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Sicos et Cie. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate 2%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

cyclopentasiloxane, dimethicone crosspolymer, fragrance, limonene, benzyl salicylate, benzyl alcohol, disodium stearoyl glutamate, butylphenyl methylpropional, BHT, aluminum hydroxide, alumina, hexyl cinnamal; may contain: mica, red 36, yellow 5 lake, iron oxides, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GIORGIO ARMANI FACE FABRIC SECOND SKIN NUDE MAKEUP BROAD SPECTRUM SPF 12 SUNSCREEN 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-575
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
MICA (UNII: V8A1AW0880)
D&C RED NO. 36 (UNII: OE8ZA0KN9Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-575-01	1 in 1 CARTON	12/01/2008
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-575-02	1 in 1 CARTON	12/01/2008
2		5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-575-03	1 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2008
4	NDC: 49967-575-04	1 in 1 CARTON	12/01/2008
4		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2008

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Sicos et Cie		276993581	manufacture(49967-575)