Label: AHAVA ACTIVE DEADSEA MINERALS MINERAL SUNCARE SPF 30- octocrylene spray

  • 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 February 22, 2012

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

  • Active Ingredient Section

    Drug Facts

    Active Ingredients   Avobenzone (3%)   Ensulizole (1%)   Octisalate (2%)   Octocrylene (10%)   Titanium Dioxide (1.52%)

  • Purpose Section

    Purpose  Sunscreen

  • Keep Out of reach of Children Section

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

  • Uses Section

    Uses

        * helps prevent sunburn
        * higher SPF gives more sunburn protection

  • Warnings Section

    Warnings

    For External Use Only    When using this product keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if rash or irritation develops and lasts    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions Section

    Directions

        * shake before using
        * apply liberally 30 minutes before sun exposure and as needed
        * children under 6 months of age: ask a doctor

  • Inactive Ingredient Section

    Inactive ingredients:  Aqua (Water), C12-15 Alkyl Benzoate, Cyclomethicone, Propanediol, Methylene Bis-Benzotriazolyl Tetramethtbutylphenol, Trimethoxycaprlylsilane, Sodium Hydroxide, Caprylic/Capric Triglyceride, Phenyl Trimethicone, Tricontanyl PVP, Phenoxyethanol, 1,2-Hexandiol, Caprylyl Glycol, Cetearyl Alcohol, Parfum (Fragrance), Tocopheryl (Vitamin E) Acetate, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract,  Panthenol (Pro-Vitamin B5), Disodium EDTA, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum,  Allantoin, Polyglyceryl-10 Pentastearate, Behenyl Alcohol, Sodium Stearoyl Lactylate, Potassium Cetyl Phosphate, Dunalietta Salina (Dead Sea Alga) Extract, Maris Sal (Dead Sea Water)

    The Osmotertm  Dead Sea Water
    Major Elements /in mg/L:                                            Micro Elements  /in ppml:
    Magnesium    Mg   92,000                                          Stronium     Sr         670
    Calcium         Ca   35,000                                           Boron         B          120
    Bromine         Br   14,000                                           Lithium        Li           40
    Sodium          Na    2,700                                           Manganese Mn          10
    Potassium      K      2,100                                          Barium        Ba            9   

  • Other information Section

    Other information

        * provides moderate protection against sunburn

  • Package Label

    The AHAVA Osmoter tm  A gift from nature, Dead Sea minerals are known to improve your skin's well-being and youthfulness.

    The osmoter tm is a unique blend of minerals contained in all AHAVA products. It optimizes cell metabolism, strenghtens skin against UV damage, and significantly increases moisture to keep your skin looking young and supple.

    AHAVA ACTIVE DEAD SEA MINERALS   SPRAY spf 30 mineral SUNCARE

    Sun Protection  Anti-Aging Moisturizing Spray

        * moderate UVA/UVB sunscreen
        * very water resistant

    suitable for children

    250 ml / 8.5 fl. oz

    Sun protection Anti-Aging moisturizing Spray SPF 30  enriched with Mineral Skin Osmoter tm

    Protect your skin from the damages of the sun with this quality blend (Multi-Layer Protection System tm) of highly effective sunscreens. Dead Sea minerals and seaweed, essential vitamins and moisturizing agents, all proven to be efficient in fighting premature aging. An easy-to-apply light milk.

        * Mineral Skin Osmoter tm - Ahava unique blend of Dead Sea minerals proven to reduce the damage of sun radiation.

    Suitable for children. Approved for sensitive skin. Allergy tested. Mineral oil free. Paraben free.
    Absorbs more than 90% of UVA rays (according to the Australian standards). Retains SPF after 80 minutes of activity in the water.

    Ahava advice: Avoid exposing children under 6 months of age to the sun. The use of a high sun protection factor for children is recommended (SPF 30 and up). Avoid extended exposure to the sun, even while using this product.

    www.ahava.com

    Against animal testing  PARABEN FREE ALLERGY TESTED

    A product of AHAVA Dead Sea Laboratories, Ltd. Dead Sea, israel.  Manufactures by Zohar Cosmetics Ltd. POB 16 Yerucham, israel.

    In USA: Ahava NA, 411 5th Ave. NY, 10016  1-800-366-7254

    Mineral Suncare SPF 15 Label

  • INGREDIENTS AND APPEARANCE
    AHAVA ACTIVE DEADSEA MINERALS  MINERAL SUNCARE SPF 30
    octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60289-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mL  in 250 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2.5 mL  in 250 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 250 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE7.5 mL  in 250 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.8 mL  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BISOCTRIZOLE (UNII: 8NT850T0YS)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    MAGNESIUM (UNII: I38ZP9992A)  
    CALCIUM (UNII: SY7Q814VUP)  
    BROMINE (UNII: SBV4XY874G)  
    SODIUM (UNII: 9NEZ333N27)  
    POTASSIUM (UNII: RWP5GA015D)  
    STRONTIUM (UNII: YZS2RPE8LE)  
    BORON (UNII: N9E3X5056Q)  
    LITHIUM (UNII: 9FN79X2M3F)  
    MANGANESE (UNII: 42Z2K6ZL8P)  
    BARIUM (UNII: 24GP945V5T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60289-030-30250 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2012
    Labeler - AHAVA - Dead Sea Laboratories Ltd. (600056907)
    Registrant - AHAVA - Dead Sea Laboratories Ltd. (600056907)