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

Giorgio Armani Maestro UV Skin Defense Primer Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

Giorgio Armani Maestro UV Skin Defense Primer Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc., Nippon Shikizai, Inc., Laboratoires Biocosm SARL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, butylphenyl methylpropional, hexyl cinnamal

Questions or comments?

CONTACT: GIORGIO ARMANI PARFUMS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-563
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-563-01	1 in 1 CARTON	06/01/2016
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-563-02	1 in 1 CARTON	06/01/2016
2		5 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	06/01/2016

Labeler - L'Oreal USA Products Inc. (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Nippon Shikizai, Inc.		694869178	manufacture(49967-563)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Biocosm SARL		288479491	pack(49967-563)