Super BB All in 1 Beauty Balm Powder 7836; 69514-309

Super BB All in 1 Beauty Balm Powder by

Drug Labeling and Warnings

Super BB All in 1 Beauty Balm Powder by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPER BB ALL IN 1 BEAUTY BALM POWDER- titanium dioxide, zinc oxide powder 
Markwins Beauty Brands

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Super BB All in 1 Beauty Balm Powder 7836; 69514-309

Titanium Dioxide 15%

Zinc Oxide 10%

Sunscreen

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

For external use only

Do not use on damage 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

If swallowed, get medical help or contact a Poison Control Center right away

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

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).

SUPER BB ALL IN 1 BEAUTY BALM POWDER 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69514-309
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)
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)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69514-309-02	1 in 1 CARTON	11/28/2022	12/01/2023
1	NDC: 69514-309-01	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 Drug	M020	11/28/2022	12/01/2023

Labeler - Markwins Beauty Brands (078890119)

Revised: 12/2023

Document Id: 0d99e316-e5fa-fe8e-e063-6294a90a6a0e

34390-5

Set id: f3848ce6-9913-3fb9-e053-2a95a90adca8

Version: 2

Effective Time: 20231228