AHAVA ACTIVE DEADSEA MINERALS MINERAL SUNCARE SPF 30- octocrylene spray

AHAVA ACTIVE DEADSEA MINERALS by

Drug Labeling and Warnings

AHAVA ACTIVE DEADSEA MINERALS by is a Otc medication manufactured, distributed, or labeled by AHAVA - Dead Sea Laboratories Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AHAVA ACTIVE DEADSEA MINERALS  MINERAL SUNCARE SPF 30
octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25 mL  in 250 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2.5 mL  in 250 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 250 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	7.5 mL  in 250 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.8 mL  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-030-30	250 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2012

Labeler - AHAVA - Dead Sea Laboratories Ltd. (600056907)

Registrant - AHAVA - Dead Sea Laboratories Ltd. (600056907)