IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]

IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE SPF 30 (ZINC OXIDE) LOTION [IBLANC, INC.]
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NDC 52960-201-12
Set ID 1d7f1ddb-108f-49f4-baf4-5a457ff5e08e
Category HUMAN OTC DRUG LABEL
Packager iBlanc, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    13.5% ZINC OXIDE

  • PURPOSE

    HELPS PREVENT SUNBURN

  • INDICATIONS & USAGE

  • WARNINGS AND PRECAUTIONS

    DO NOT USE ON DAMAGED OR BROKEN SKIN. KEEP OUT OF EYES.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF RASH OCCURS.

  • 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

    Advanced Sun Defense SPF30 ART 2012-08-01_LBL

  • QUESTIONS

    QUESTIONS OR COMMENTS

    CALL TOLL FREE 855-2-IBLANC

  • INGREDIENTS AND APPEARANCE
    IBLANC RESTORA-BRIGHT ELITE NATURAL SUN DEFENSE  SPF 30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52960-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52960-201-1245 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/23/2012
    Labeler - iBlanc, Inc. (078510606)
    Registrant - iBlanc, Inc. (078510606)

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