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 Type HUMAN OTC DRUG Item Code (Source) NDC:54272-201
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CORALLINA OFFICINALIS (UNII: 4004498D06)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
OAT (UNII: Z6J799EAJK)  
ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)  
10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)  
SEBACIC ACID (UNII: 97AN39ICTC)  
1,10-DECANEDIOL (UNII: 5I577UDK52)  
BETAINE (UNII: 3SCV180C9W)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PROLINE (UNII: 9DLQ4CIU6V)  
ALANINE (UNII: OF5P57N2ZX)  
SERINE (UNII: 452VLY9402)  
MAGNESIUM LACTATE (UNII: MT6QI8324A)  
POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SORBIC ACID (UNII: X045WJ989B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54272-201-11 30 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/21/2013
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