Drug Labeling and Warnings

Drug Details [pdf]

AHAVA ACTIVE DEADSEA MINERALS MINERAL SUNCARE SPF 50 FACE- octocrylene cream 
AHAVA - Dead Sea Laboratories Ltd.

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.

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Active Ingredient Section

Drug Facts

Active Ingredients
   Avobenzone (3%)   Ensulizole (1%)   Octisalate (5%)   Octocrylene (10%)   Titanium Dioxide (5%)

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

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

Inactive Ingredients Section

Inactive ingredients: Aqua(Water), Trimethoxycaprylylsilane, Methylene Bis Benzotriazolyl Tetramethylbutylphenol, Cyclomethicone, C12-15 Alkyl benzoate, Polyglyceryl-10 Pentastearate, Behenyl Alcohol, Sodium stearoyl Lactylate, Cetearyl Alcohol, Propanediol, Sodium hydroxide, Tricontanyl PVP, Phenoxyethanol, Phenyl Ttimethicone, Diethylamino Hydroxybenzoyl Hexyl Benozate, Potassium Cetyl Phosphate, 1,2-Hexandiol, Caprylyl Glycol, Parfum (Fragrance), Xanthan Gum, Ethylhexylglycerin, Tocopheryl (Vitamin E) Acetate, Disodium EDTA, Allantoin, PEG-40 Stearate, BHT, Panthenol (Pro-Vitamin B5), Aloe Barbadensis  Leaf 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   spf 50 mineral SUNCARE

Sun Protection  Anti-Aging Facial Moisturizer

    * highUVA/UVB sunscreen
    * very water resistant

suitable for children

60 ml / 2.1 fl. oz

Sun protection Anti-Aging Facial Moisturizer SPF 50  enriched with Mineral Skin Osmoter tm

The superior protective moisturizer (Multi-Layer Protection System tm) blends highly effective sunscreens. Dead Sea minerals and seaweed, essential vitamins and moisturizing agents, all proven to fight premature aging efficiently. Weightless and quickly absorbed, it provides the epidermis with quality anti-aging nutrients and natural soothing agents, leaving the skin protected and smooth.

    * 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.

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 50 Face Label

AHAVA ACTIVE DEADSEA MINERALS  MINERAL SUNCARE SPF 50 FACE
octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60289-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 60 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.6 g  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 60 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.8 g  in 60 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
BISOCTRIZOLE (UNII: 8NT850T0YS)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
DOCOSANOL (UNII: 9G1OE216XY)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
2-(4-(DIETHYLAMINO)-2-HYDROXYBENZOYL)BENZOIC ACID (UNII: X4K32L28QB)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALLANTOIN (UNII: 344S277G0Z)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
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: 60289-051-511 in 1 CARTON02/01/201212/31/2014
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201212/31/2014
Labeler - AHAVA - Dead Sea Laboratories Ltd. (600056907)

Revised: 9/2019