Super BB Beauty Balm Powder 7836, 7837, 71413-215

Super BB Beauty Balm Powder by

Drug Labeling and Warnings

Super BB Beauty Balm Powder by is a Otc medication manufactured, distributed, or labeled by Baja Fur, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPER BB BEAUTY BALM POWDER SPF 30- titanium dioxide, zinc oxide powder 
Baja Fur, S.A. de C.V.

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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Super BB Beauty Balm Powder 7836, 7837, 71413-215

Active ingredients

Titanium Dioxide 15%

Zinc Oxide 10%

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

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

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 preotection measures including:

limit time in the sun, especially from 10 a.m. - 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

Other information

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

Inactive ingredients

Mica, Zinc Stearate, Octyldodecyl Stearoyl Stearate, Dimethicone, Calcium Aluminum Borosilicate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Lauroyl Lysine, Boron Nitride, Triethylhexanoin, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, o-Cymen-5-ol, Silica, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Salix Alba (Willow) Bark Extract, Glycerin, Water/Eau, Lysolecithin, Perilla Ocymoides Seed Oil, Synthetic Fluorphlogopite, Tin Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

Questions or comments?

Call toll free 1-800-227-0333

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Carton PDP

SUPER BB BEAUTY BALM POWDER  SPF 30
titanium dioxide, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71413-215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MICA (UNII: V8A1AW0880)  
ZINC STEARATE (UNII: H92E6QA4FV)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
LAUROYL LYSINE (UNII: 113171Q70B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
GLYCERIN (UNII: PDC6A3C0OX)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)  
WATER (UNII: 059QF0KO0R)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71413-215-021 in 1 CARTON12/27/2012
1NDC: 71413-215-018.3 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/27/2012
Labeler - Baja Fur, S.A. de C.V. (821533098)

Revised: 9/2021
 

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