Your browser does not support JavaScript! BRIGHTEN SPF 30 (ZINC OXIDE OCTINOXATE) CREAM [CEN BEAUTY LLC]
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BRIGHTEN SPF 30 (zinc oxide octinoxate) cream
[CEN BEAUTY LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENT

ZINC OXIDE 15%

OCTINOXATE 6%

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 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

  • Apply on to clean and dry face morning and night, avoiding the delicate eye area.
  • Apply 15 minutes before sun exposure. May be used daily.
  • Consult your physician before use.

Other Information

  • STORE AT 15-30°C (59-86°F)
  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

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
 
CEN BEAUTY LLC

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