GIORGIO ARMANI MAESTRO UV SKIN DEFENSE PRIMER BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, octinoxate and octisalate 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 ingredients

Avobenzone 3%

Octinoxate 7.49%

Octisalate 5%

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

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:

●  shake well before 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

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

Inactive ingredients

c12-15 alkyl benzoate, water, butylene glycol, methyl methacrylate crosspolymer, polymethylsilsesquioxane, vinyl dimethicone/methicone silsesquioxane crosspolymer, isononyl isononanoate, glycerin, dicaprylyl carbonate, pentylene glycol, polyglyceryl-6 polyricinoleate, fragrance, tocopherol, sodium chloride, phenoxyethanol, stearyl glycyrrhetinate, polyglyceryl-2 isostearate, limonene, benzyl salicylate, benzyl alcohol, linalool, tetrasodium EDTA, BHT, hexyl cinnamal

Questions or comments?

CONTACT: GIORGIO ARMANI PARFUMS

LUXURY PRODUCTS LLC, 10 HUDSON YARDS, NEW YORK, NY 10001

image of a label

GIORGIO ARMANI MAESTRO UV SKIN DEFENSE PRIMER BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, octinoxate and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-563
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-563-011 in 1 CARTON06/01/201612/30/2020
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-563-021 in 1 CARTON06/01/201612/30/2020
25 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 finalpart35206/01/201612/30/2020
Labeler - L'Oreal USA Products Inc. (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Nippon Shikizai, Inc.692076308manufacture(49967-563)
Establishment
NameAddressID/FEIBusiness Operations
BPS60272259304pack(49967-563)

Revised: 12/2021
 
L'Oreal USA Products Inc.