Label: ACTIBEAU CAMELLIA NATURAL MINERAL UV DEFENSE SUNSCREEN- zinc oxide, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 3, 2019

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  • ACTIVE INGREDIENT

    Zinc Oxide 10.952%
    Titanium Dioxide 4.8184%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

  • 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 using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    WATER, CYCLOPENTASILOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLENE GLYCOL, ETHYLHEXYL PALMITATE, COCOS NUCIFERA (COCONUT) OIL, CETYL PEG/PPG-10/1 DIMETHICONE, DICAPRYLYL CARBONATE, NIACINAMIDE, ISOPROPYL MYRISTATE, GLYCERIN, 1,2-HEXANEDIOL, SODIUM CHLORIDE, CAPRYLYL METHICONE, QUATERNIUM-18 HECTORITE, EUPHORBIA CERIFERA (CANDELILLA) WAX, DIMETHICONE CROSSPOLYMER, ALUMINUM HYDROXIDE, BORON NITRIDE, PENTAERYTHRITYL TETRAETHYLHEXANOATE, SORBITAN ISOSTEARATE, POLYHYDROXYSTEARIC ACID, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, COCO-CAPRYLATE/CAPRATE, FRAGRANCE, DIMETHICONE, C12-15 ALKYL BENZOATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PROPYLENE CARBONATE, FERRIC OXIDE YELLOW (CI 77492), NEOPENTYL GLYCOL DIETHYLHEXANOATE, TOCOPHERYL ACETATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ADENOSINE, FERRIC OXIDE RED (CI 77491), DISODIUM EDTA, CAMELLIA JAPONICA SEED OIL, D&C RED NO. 33 (CI 17200), NELUMBO NUCIFERA FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, SOPHORA JAPONICA FLOWER EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT, CAMELLIA JAPONICA FLOWER EXTRACT, PRUNUS MUME FLOWER EXTRACT, PYRUS COMMUNIS (PEAR) FLOWER EXTRACT

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ACTIBEAU CAMELLIA NATURAL MINERAL UV DEFENSE SUNSCREEN 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73016-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION109.52 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE48.187 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    QUATERNIUM-18 HECTORITE (UNII: IIS3YBV1XX)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ADENOSINE (UNII: K72T3FS567)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)  
    PRUNUS MUME FLOWER (UNII: 2N8872050J)  
    PYRUS COMMUNIS FLOWER (UNII: P6Y3X4TOIW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73016-003-021 in 1 CARTON04/03/2019
    1NDC:73016-003-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/03/2019
    Labeler - ACTIVEBEUTY CO.,LTD (695911007)
    Registrant - ACTIVEBEUTY CO.,LTD (695911007)
    Establishment
    NameAddressID/FEIBusiness Operations
    ACTIVEBEUTY CO.,LTD695911007manufacture(73016-003)
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