GIORGIO ARMANI FACE FABRIC SECOND SKIN NUDE MAKEUP BROAD SPECTRUM SPF 12 SUNSCREEN- octinoxate lotion 
L'Oreal USA Products Inc

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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Drug Facts

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

image of a carton

GIORGIO ARMANI FACE FABRIC SECOND SKIN NUDE MAKEUP BROAD SPECTRUM SPF 12 SUNSCREEN 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-575
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-575-011 in 1 CARTON12/01/200810/06/2018
140 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-575-021 in 1 CARTON12/01/200810/06/2018
25 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:49967-575-031 mL in 1 PACKET; Type 0: Not a Combination Product12/01/200810/06/2018
4NDC:49967-575-041 in 1 CARTON12/01/200810/06/2018
415 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/200810/06/2018
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Sicos et Cie276993581manufacture(49967-575)

Revised: 1/2023
 
L'Oreal USA Products Inc