Label: ALBA EVEN ADVANCED MINERAL CC CREAM LIGHT TO MEDIUM SPF15- 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 October 24, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Zinc Oxide 4.0%

    Titanium Dioxide 3.5%

  • DOSAGE & ADMINISTRATION

    Cream.For sunscreen use apply liberallyafter cleansing and 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating

  • PURPOSE

    Sunscreen

  • 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 use and ask a doctor if skin rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

  • INACTIVE INGREDIENT

    Water, Caprylic Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes,Polyglyceryl-2 Sesquioleate, Glycerin, Polyglyceryl-3 Ricinoleate, Crambe Abyssinica Seed Oil, Aloe Barbadensis Leaf Juice(1), Polyhydroxystearic Acid, Echinacea Purpurea Extract, Polygonum Aviculare Extract, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter,Propanediol, Algae Extract, Beta Vulgaris (Beet)Root Extract, Chlorella Pyrenoidosa Extract, Dictyopteris Membranacea Extract, Chondrus Crispus Extract, Enteromorpha Compressa Extract, Laminaria Digitata Extract, Macrocystis Pyrifera Extract, Pancratium Maritimum Extract, Spirulina Maxima Extract, Ulva Lactuca Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil, Brassica Campestris (Rapeseed) Seed Oil, Alumina, Calcium Ascorbate, Caesalpinia Spinosa Gum, Hydrolyzed Corn Starch, Jojoba Esters, Lactic Acid, Magnesium Stearate, Coco-Caprylate/Caprate, Magnesium Sulfate, Magnesium Stearate, Oryza Sativa (Rice) Starch, p-Anisic Acid, Silica, Sodium Chloride,Sodium Hyaluronate, Sorbitan Sesquioleate, Stearic Acid, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Bismuth Oxychloride, Iron Oxides, Mica.

    (1) Certified Organicf Ingredient

  • INDICATIONS & USAGE

    Helps prevents sunburns. If uses as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.

  • PRINCIPAL DISPLAY PANEL

    tube labelcarton label

  • INGREDIENTS AND APPEARANCE
    ALBA EVEN ADVANCED MINERAL CC CREAM LIGHT TO MEDIUM SPF15 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    SEAWEED (UNII: 477TV3P5UX)  
    ULVA COMPRESSA (UNII: SXZ209FM33)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BETA VULGARIS (UNII: 4G174V5051)  
    CHLORELLA PYRENOIDOSA (UNII: 591BV50NV8)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    NARCISSUS TAZETTA BULB (UNII: K17762966S)  
    SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CALCIUM ASCORBATE (UNII: 183E4W213W)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ANISE (UNII: 21C2F5E8RE)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    ULVA LACTUCA (UNII: PHR3P25W6Y)  
    DICTYOPTERIS POLYPODIOIDES (UNII: 83H6O5GR42)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2032-21 in 1 CARTON07/25/2013
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/25/2013
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Registrant - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture(61995-2032)