Label: FACE AND BODY MINERAL SPF - TINTED- titanium dioxide, zinc oxide aerosol, foam

  • NDC Code(s): 81535-210-01
  • Packager: Flawless Skin Care, LLC (dba Abby Skin Clinic)
  • 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 March 17, 2020

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  • ACTIVE INGREDIENTS:

    Titanium Dioxide 3%

    Zinc Oxide 10%

  • PURPOSE:

    Sunscreen

    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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    • Shake well before using.
    • Push nozzle up to release safety tab.
    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
      • After 40 minutes of swimming or sweating
      • Immediately after towel drying
      • At least every 2 hours
    • Children under 6 months: Ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 am-2 pm
      • Wear long-sleeved shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENTS:

    Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Trans-1,3,3,3-TetrafIuoropropene, Triacontanyl PVP, Triethoxycaprylylsilane,Trimethoxycaprylylsilane, Water

  • OTHER INFORMATION:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
    • Store between 68° to 104° F (20° to 40° C).
    • Do not store at temperatures above 120° F.
  • Principal Display Panel - 100 g Can Label

    ABBY SKIN CARE

    ABBY ODIAMAR PACLIBAR

    FACE & BODY
    MINERAL SPF
    TINTED

    Oil Free Mousse Sunscreen

    broad spectrum SPF 30

    water resistant (40 mins)

    • Great for all skin types
    • Photo-stable will not degrade in sunlight
    • FREE of chemical sunscreen filters, dyes,
      fragrances, oils and preservatives
    • Reef friendly
    • non-comedogenic

    Net Wt. 3.5 oz | 100 g

    Principal Display Panel - 100 g Can Label
  • INGREDIENTS AND APPEARANCE
    FACE AND BODY MINERAL SPF - TINTED 
    titanium dioxide, zinc oxide aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81535-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81535-210-01100 g in 1 CAN; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/24/2018
    Labeler - Flawless Skin Care, LLC (dba Abby Skin Clinic) (031934930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(81535-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(81535-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keystone Industries014769301PACK(81535-210)
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