Bronze Booster BB Bronzer-PF-Tecno

Bronze Booster Beauty Balm BB Bronzer by

Drug Labeling and Warnings

Bronze Booster Beauty Balm BB Bronzer by is a Otc medication manufactured, distributed, or labeled by Physicians Formula Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BRONZE BOOSTER BEAUTY BALM BB BRONZER SPF 20- titanium dioxide powder 
Physicians Formula 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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Bronze Booster BB Bronzer-PF-Tecno

Warning:  For external use only.  Do notuse 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

Active Ingredient: Titanium Dioxide 6.0%

BRONZE BOOSTER BEAUTY BALM BB BRONZER  SPF 20
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-168
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
NYLON-12 (UNII: 446U8J075B)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
INOSITOL (UNII: 4L6452S749)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHICONE (20 CST) (UNII: 6777U11MKT)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MANGANESE VIOLET (UNII: 72M48QQV8Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31645-168-02	1 in 1 CARTON	01/01/2014	12/31/2019
1	NDC: 31645-168-01	9 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 final	part352	01/01/2014	12/31/2019

Labeler - Physicians Formula Inc (021261805)

Revised: 12/2019

Document Id: 9a04509d-2982-fd96-e053-2995a90ad178

34390-5

Set id: d6819879-ff51-45ca-89bc-de2b5e288ebe

Version: 4

Effective Time: 20191218

 

Physicians Formula Inc