Drug Labeling and Warnings

Drug Details [pdf]

GIORGIO ARMANI MAESTRO FUSION MAKEUP COMPACT BROAD SPECTRUM SPF 29 SUNSCREEN- octinoxate cream 
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.

----------

Active ingredient

Octinoxate 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:

● 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

dimethicone, dicaprylyl carbonate, octyldodecyl neopentanoate, phenyl trimethicone, boron nitride, hydrogenated jojoba oil, hydrogenated polyisobutene, silica dimethyl silylate, polyethylene, disodium stearoyl glutamate, aluminum hydroxide, tocopheryl acetate, argania spinosa kernel oil; may contain: titanium dioxide, bismuth oxychloride, iron oxides

GIORGIO ARMANI MAESTRO FUSION MAKEUP COMPACT BROAD SPECTRUM SPF 29 SUNSCREEN 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BORON NITRIDE (UNII: 2U4T60A6YD)
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-803-01	1 in 1 CARTON	08/01/2013	11/10/2017
1		9 g in 1 PACKAGE; 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	08/01/2013	11/10/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Beaute Recherche & Industries		398540000	manufacture(49967-803)

Revised: 8/2019

Document Id: d80e3501-26e6-46ff-b997-edd9e353ca1f

34390-5

Set id: 69be4774-e457-4077-ac23-2ac5a9483ffa

Version: 3

Effective Time: 20190826