GIORGIO ARMANI POWER FABRIC LONG WEAR HIGH COVER FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN- octinoxate lotion 
L'Oreal USA Products Inc.

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Drug Facts

Active ingredient

Octinoxate 6.7%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Flammable until dry.

Do not use near fire, flame, or heat.

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

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

     ● limit time in the sun, especially from 10 a.m. – 2 p.m.

     ● wear long-sleeved shirts, pants, hats, and sunglasses

● 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

cyclohexasiloxane, water, dimethicone, vinyl dimethicone/methicone silsesquioxane crosspolymer, propanediol, alcohol denat., butylene glycol, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, synthetic fluorphlogopite, polyglyceryl-4 isostearate, phenoxyethanol, magnesium sulfate, disodium stearoyl glutamate, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, PEG/PPG-18/18 dimethicone, fragrance, dimethicone/vinyl dimethicone crosspolymer, aluminum hydroxide, isobutene, benzyl salicylate, hexyl cinnamal, benzyl alcohol, BHT, limonene, linalool, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopherol, may contain: titanium dioxide, iron oxides

Questions or comments?

CONTACT: GIORGIO ARMANI PARFUMS

LUXURY PRODUCTS LLC

10 HUDSON YARDS, NEW YORK, NY 10001

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GIORGIO ARMANI POWER FABRIC LONG WEAR HIGH COVER FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-349
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ISOBUTANE (UNII: BXR49TP611)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-349-011 in 1 CARTON08/10/201611/30/2023
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-349-021 in 1 CARTON08/10/201611/30/2023
218 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:49967-349-031 in 1 CARTON08/10/201611/30/2023
35 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:49967-349-041 mL in 1 PACKET; Type 0: Not a Combination Product08/10/201611/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/10/201611/30/2023
Labeler - L'Oreal USA Products Inc. (002136794)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(49967-349) , pack(49967-349)
Establishment
NameAddressID/FEIBusiness Operations
Socoplan276221405pack(49967-349)
Establishment
NameAddressID/FEIBusiness Operations
BPS60272259304pack(49967-349)

Revised: 12/2023
 
L'Oreal USA Products Inc.