Lancome Paris Star Bronzer Long Lasting Bronzer SPF 15 by L'Oreal USA Products Inc Drug Facts

Lancome Paris Star Bronzer Long Lasting Bronzer SPF 15 by

Drug Labeling and Warnings

Lancome Paris Star Bronzer Long Lasting Bronzer SPF 15 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LANCOME PARIS STAR BRONZER LONG LASTING BRONZER SPF 15- octinoxate powder 
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 7.5%

Directions

Apply before sun exposure. For sunscreen protection, reapply frequently.

Warnings

FOR EXTERNAL USE ONLY. 

When using this product

AVOID CONTACT WITH EYES. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. 

Stop use and ask a doctor if

SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR. 

Keep out of reach of children.

Not to be swallowed.

Inactive ingredients

CALCIUM CARBONATE, SILICA, CALCIUM SULFATE, ISOCETYL STEARATE, MAGNESIUM STEARATE, ALOE BARBADENSIS LEAF JUICE, ALUMINA, ETHYLHEXYL-GLYCERIN, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL; MAY CONTAIN: MICA, BETA-CAROTENE, TITANIUM DIOXIDE, BISMUTH OXYCHLORIDE, IRON OXIDES.

LANCOME PARIS STAR BRONZER LONG LASTING BRONZER SPF 15 
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-549
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CALCIUM SULFATE (UNII: WAT0DDB505)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-549-01	1 in 1 CARTON	04/15/2011	01/16/2014
1		13 g in 1 CONTAINER; 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	04/15/2011	01/16/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		185931458	manufacture(49967-549)

Revised: 1/2020

Document Id: 80118e3b-b20e-4ed9-b3b2-c52cb7982b5d

34390-5

Set id: ec3ab2cc-ff2b-4e01-bd4d-a6f99f7ce9aa

Version: 3

Effective Time: 20200117

 

L'Oreal USA Products Inc