Label: IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 52960-201-12 - Packager: iBlanc, Inc.
- 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 October 26, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: AQUA (WATER), CAPRYLIC/CAPRIC TRIGLYCERIDE, CANDELILLA/JOJOBA/RICE BRAN POLYGLYCERYL-3 ESTERS, GLYCERIN, ISODECYL NEOPENTANOATE, ETHYL MACADAMIATE, ALEURITES MOLUCCANA SEED OIL, HYDROXYPROPYL STARCH PHOSPHATE, GLYCERYL STEARATE, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, ERGOTHIONEINE (L), HORDEUM DISTICHON (BARLEY) EXTRACT, MACADAMIA TERNIFOLIA SEED OIL, PORPHYRA UMBITICALIS (RED ALGAE) EXTRACT, SANTALUM ALBUM (SANDALWOOD) EXTRACT, PHELLODENDROM AMURENSE BARK EXTRACT, GLYCERYL ISOSTEARATE, SODIUM STEROYL LACTYLATE, POLYGLYCERYL-10 PENTASTEARATE, POLYHYDROXYSTEARIC ACID, TOCOPHEROL (D-ALPHA), TOCOPHERYL ACETATE (D-ALPHA), LECITHIN, MALIC ACID (L), LONICERA CAPRIFOLIUM (HONEYSUCKLE) FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, POTASSIUM CETYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, ALCOHOL, CETEARYL ALCOHOL, BEHENYL ALCOHOL, HYDROXYPROPYL METHYLCELLULOSE, SODIUM LACTATE, PHYTIC ACID, CITRIC ACID, SODIUM HYDROXIDE.
- PRINCIPAL DISPLAY PANEL
- QUESTIONS
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INGREDIENTS AND APPEARANCE
IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52960-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85) CANDELILLA WAX (UNII: WL0328HX19) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) RICE BRAN OIL (UNII: LZO6K1506A) GLYCERIN (UNII: PDC6A3C0OX) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW) HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) ERGOTHIONEINE (UNII: BDZ3DQM98W) BARLEY (UNII: 5PWM7YLI7R) MACADAMIA OIL (UNII: 515610SU8C) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) SANDALWOOD (UNII: 3641YW25N2) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MALIC ACID, L- (UNII: J3TZF807X5) LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) ALCOHOL (UNII: 3K9958V90M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DOCOSANOL (UNII: 9G1OE216XY) HYPROMELLOSES (UNII: 3NXW29V3WO) SODIUM LACTATE (UNII: TU7HW0W0QT) PHYTIC ACID (UNII: 7IGF0S7R8I) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52960-201-12 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/23/2012 Labeler - iBlanc, Inc. (078510606) Registrant - iBlanc, Inc. (078510606)
