SUPER BB BEAUTY BALM POWDER- titanium dioxide, zinc oxide powder

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 LINA GALE, INC, Lina Gale Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Principle Display Panel

INGREDIENTS AND APPEARANCE

SUPER BB BEAUTY BALM POWDER 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69514-138
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MICA (UNII: V8A1AW0880)
ZINC STEARATE (UNII: H92E6QA4FV)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LAUROYL LYSINE (UNII: 113171Q70B)
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)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
WATER (UNII: 059QF0KO0R)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69514-138-02	1 in 1 CARTON	12/27/2012
1	NDC: 69514-138-01	8.3 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	12/27/2012

Labeler - LINA GALE, INC (078890119)

Establishment
Name	Address	ID/FEI	Business Operations
Lina Gale Inc		078890119	manufacture(69514-138)