Label: BRIGHTEN SPF 30- zinc oxide octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54272-201-11 - Packager: CEN BEAUTY LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 28, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRIGHTEN SPF 30
zinc oxide octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54272-201 Route of Administration TOPICAL 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)