AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 50

Dosage form: cream
Ingredients: OCTOCRYLENE 25mL in 250mL, ENSULIZOLE 2.5mL in 250mL, OCTISALATE 12.5mL in 250mL, AVOBENZONE 7.5mL in 250mL, TITANIUM DIOXIDE 12.5mL in 250mL
Labeler: AHAVA - Dead Sea Laboratories Ltd.
NDC Code: 60289-050

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.

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

Warning 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 Moisturizer


    * highUVA/UVB sunscreen
    * very water resistant

suitable for children

250 ml / 8.5 fl. oz

Sun protection Anti-Aging moisturizer SPF 50  enriched withMineral 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. A quickly absorbed weightless cream.

    * 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

724431C

AHAVA ACTIVE DEADSEA MINERALS  MINERAL SUNCARE SPF 50
octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60289-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE25 mL  in 250 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE2.5 mL  in 250 mL
OCTISALATE (OCTISALATE) OCTISALATE12.5 mL  in 250 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE7.5 mL  in 250 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE12.5 mL  in 250 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
TRIMETHOXYCAPRYLYLSILANE 
BISOCTRIZOLE 
CYCLOMETHICONE 
ALKYL (C12-15) BENZOATE 
POLYGLYCERYL-10 OLEATE 
DOCOSANOL 
SODIUM STEAROYL LACTYLATE 
CETOSTEARYL ALCOHOL 
PROPANEDIOL 
SODIUM HYDROXIDE 
TRIACONTANYL PVP (WP-660) 
PHENOXYETHANOL 
PHENYL TRIMETHICONE 
2-(4-(DIETHYLAMINO)-2-HYDROXYBENZOYL)BENZOIC ACID 
POTASSIUM CETYL PHOSPHATE 
1,2-HEXANEDIOL 
CAPRYLYL GLYCOL 
XANTHAN GUM  
ETHYLHEXYLGLYCERIN 
ALPHA-TOCOPHEROL ACETATE 
EDETATE DISODIUM 
ALLANTOIN 
PEG-40 STEARATE 
BUTYLATED HYDROXYTOLUENE 
PANTHENOL 
ALOE VERA LEAF 
DUNALIELLA SALINA 
MAGNESIUM  
CALCIUM 
BROMINE 
SODIUM 
POTASSIUM 
STRONTIUM 
BORON 
LITHIUM 
MANGANESE 
BARIUM 
Packaging
#Item CodePackage Description
1NDC:60289-050-50250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2012
Labeler - AHAVA - Dead Sea Laboratories Ltd. (600056907)
Registrant - AHAVA - Dead Sea Laboratories Ltd. (600056907)

Revised: 02/2012
 
AHAVA - Dead Sea Laboratories Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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