BRIGHTEN SPF 30- zinc oxide and octinoxate cream 
CEN BEAUTY LLC

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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ACTIVE INGREDIENT

ZINC OXIDE 15%

OCTINOXATE 6%

PURPOSE

SUNSCREEN

USES

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

Other Information

INGREDIENTS

aqua (water), cyclopentasiloxane, PEG-10 dimethicone, dimethicone, butylene glycol, cyclohexasiloxane, glycerin, corallina officinalis extract, algae extract, avena sativa (oat) kernel extract, angelica sinensis extract, 10-hydroxydecanoic acid, sebacic acid, 1,10-decanediol acid, betaine, dimethicone/vinyl dimethicone crosspolymer, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, lecithin, dimethicone/PEG-10/15 crosspolymer, dimethicone/vinyl dimethicone crosspolymer, triethoxycaprylylsilane, decamethylcyclopentasiloxane, trifluoromethyl C1-C4 alkyl dimethicone, quaternium-90 bentonite, butylene glycol, sodium chloride, sodium citrate, ethylhexylglycerin, propylene carbonate, propylene glycol, potassium sorbate, methylisothiazolinone, iodopropynyl butylcarbamate, phenoxyethanol

BB_Brightening Day Cream-SPF-30 PL329b

BB_Brightening Day Cream-SPF-30_1oz_Tubes_ARTWORK_FR

BRIGHTEN  SPF 30
zinc oxide octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54272-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE15 g  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
GLYCERIN 
CORALLINA OFFICINALIS 
PORPHYRA UMBILICALIS 
OAT 
ANGELICA SINENSIS WHOLE 
10-HYDROXYDECANOIC ACID 
SEBACIC ACID 
1,10-DECANEDIOL 
BETAINE 
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) 
LECITHIN, SOYBEAN 
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE 
PROLINE 
ALANINE 
SERINE 
MAGNESIUM LACTATE 
POTASSIUM LACTATE 
LECITHIN, SOYBEAN 
GLYCERIN 
MALTODEXTRIN 
ETHYLHEXYLGLYCERIN 
SODIUM CITRATE 
XANTHAN GUM 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM 
MAGNESIUM CHLORIDE 
BENZYL ALCOHOL 
SORBIC ACID 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54272-201-1130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/21/2013
Labeler - CEN BEAUTY LLC (078664118)
Registrant - CEN BEAUTY LLC (078664118)

Revised: 2/2013
Document Id: ec0b39fc-fb2a-4269-b9c8-77deed734b95
Set id: d5c19a00-c110-4fa5-8573-bbdf3c52fab5
Version: 1
Effective Time: 20130228
 
CEN BEAUTY LLC