Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

GIORGIO ARMANI MAESTRO SUNSCREEN FUSION MAKEUP SPF 15- 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 3%

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:

• 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

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

Inactive ingredients

cyclohexasiloxane, dimethicone, isododecane, alcohol denat., vinyl dimethicone/methicone silsesquioxane crosspolymer, phenyl trimethicone, acrylates/polytrimethylsiloxymethacrylate copolymer, PEG-10 dimethicone, disteardimonium hectorite, fragrance, nelumbium speciosum flower extract, limonene, benzyl salicylate, synthetic fluorphlogopite, linalool, benzyl alcohol, propylene carbonate, caprylic/capric triglyceride, disodium stearoyl glutamate, water, citrus aurantium amara (bitter orange) flower oil, butylphenyl methylpropional, aluminum hydroxide, hexyl cinnamal; may contain: iron oxides, titanium dioxide

GIORGIO ARMANI MAESTRO SUNSCREEN FUSION MAKEUP SPF 15 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-713
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
WATER (UNII: 059QF0KO0R)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
FERROUS OXIDE (UNII: G7036X8B5H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-713-01	1 in 1 CARTON	06/01/2012	11/30/2017
1		30 mL in 1 BOTTLE, DROPPER; 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	06/01/2012	11/30/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-713)

Revised: 8/2019

Document Id: 80f54ad8-d90a-4cce-b312-7d60ff89ada1

34390-5

Set id: 9704841a-a6d9-4bf8-b89a-23521d375a6a

Version: 3

Effective Time: 20190827