Drug Labeling and Warnings

Drug Details [pdf]

AHAVA ACTIVE DEADSEA MINERALS MINERAL SUNCARE SPF 15- octocrylene spray 
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 (2.5%)   Ensulizole (1%)   Octisalate (3%)   Octocrylene (8%)   Titanium Dioxide (1.25%)

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), Cyclomethicone, C12-15 Alkyl Benzoate, Propanediol, Trimethoxycaprlylsilane, Sodium Hydroxide, Phenyl Trimethicone, Tricontanyl PVP, Phenoxyethanol, 1,2-Hexandiol, Caprylyl Glycol, Cetearyl Alcohol, Parfum (Fragrance), Ethylhexylglycerin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Disodium EDTA, Allantoin, Polyglyceryl-10 Pentastearate, Behenyl Alcohol, Sodium Stearoyl Lactylate, Tocopheryl (Vitamin E) Acetate, Potassium Cetyl,, Phosphate, Panthenol (Pro-Vitamin B5), Aloe Barbadensis Leaf Extract, Dunaliella 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

PRINCIPAL DISPLAY PANEL - 250 ml Bottle Carton

AHAVA
ACTIVE DEADSEA MINERALS

spray

spf 15

mineral
suncare

Sun Protection
Anti-Aging Moisturizing Spray

  • moderate UVA/UVB sunscreen
  • very water resistant

250 ml / 8.5 fl. oz

PRINCIPAL DISPLAY PANEL - 250 ml Bottle Carton
AHAVA ACTIVE DEADSEA MINERALS  MINERAL SUNCARE SPF 15
octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60289-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 g  in 250 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2.5 g  in 250 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE7.5 g  in 250 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE6.25 g  in 250 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.125 g  in 250 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PROPANEDIOL (UNII: 5965N8W85T)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALLANTOIN (UNII: 344S277G0Z)  
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
DOCOSANOL (UNII: 9G1OE216XY)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
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: 60289-015-151 in 1 CARTON01/01/201212/31/2014
1250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/201212/31/2014
Labeler - AHAVA - Dead Sea Laboratories Ltd. (600056907)

Revised: 10/2019