AHAVA ACTIVE DEADSEA MINERALS  TIME TO HYDRATE ESSENTIAL MOISTURIZING BROAD SPECTRUM SPF15- avobenzone, octisalate, and octocrylene lotion 
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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AHAVA ACTIVE DEADSEA MINERALS
TIME TO HYDRATE ESSENTIAL MOISTURIZING BROAD SPECTRUM SPF15

Drug Facts

Active ingredients

Butyl Methoxydibenzoylmethane [3%]
Ethylhexyl Salicylate [5%]
Octocrylene [2.71%]

Purpose

sunscreens

Uses

  • helps prevent sunburn

Warnings

For External Use Only

When using this product keep out of eyes. Rinse with water to remove

Stop use and consult a doctor if rash or irritation develops and lasts

Do not use on damaged or broken skin

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

Directions

  • apply liberally and evenly to clean face 15 minutes before sun exposure
  • children under 6 months of age: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10a.m.-2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredients

1,2 Hexanediol, Alanine, Allantoin, Aloe Barbadensis Leaf Juice, Aqua (Mineral Spring Water), Aqua (Water), Ascorbyl Palmitate, Benzyl Alcohol, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Caprylyl Glycol, Cetearyl Olivate, Cetyl Palmitate, Cetyl Phosphate, Cinnamomum Cassia Bark Extract, Commiphora Abyssinica Resin Extract, Creatine, Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Dehydroacetic Acid, Dimethicone, Disodium Lauriminodipropionate Tocopheryl Phosphates, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Helianthus Annuus (Sunflower) Sprout Extract, Hydrogenated Vegetable Glycerides Citrate, Isostearyl Isostearate, Lecithin, Magnesium Aspartate, Maris Aqua (Dead Sea Water), Nylon 6/12, Octyldodecyl Neopentanoate, Opuntia Ficus-Indica Fruit Extract, Panthenol (Pro Vitamin B5), Parfum (Fragrance), Peg-40 Stearate, Phenoxyethanol, Porphyra Umbilicalis Extract, Propanediol (Corn derived Glycol), Propylene Carbonate, Propylene Glycol, Pseudoalteromonas Ferment Extract, PVP, Quaternium-18 Hectorite, Saccharide Hydrolysate, Salicylic Acid, Sanguisorba Officinalis Root Extract, Sodium Hyaluronate, Sorbitan Olivate, Sorbitan Palmitate, Sorbitan Tristearate, Squalene (Phytosqualene), Tocopherol (Vitamin E), Urea, Xanthan Gum, Zingiber Officinale (Ginger) Root Extract.

Other information

  • Protect the product in this container from excessive heat and direct sun

Questions or comments

Call toll free 1-800-366-7254

Dist: AHAVA N.A. LLC, NY, NY, 10016

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

AHAVA

ACTIVE DEADSEA MINERALS

TIME TO HYDRATE

ESSENTIAL
MOISTURIZING LOTION
BROAD SPECTRUM
SPF15

50 ml e 1.7 fl.oz

Principal Display Panel - 50 ml Tube Carton
AHAVA ACTIVE DEADSEA MINERALS   TIME TO HYDRATE ESSENTIAL MOISTURIZING BROAD SPECTRUM SPF15
avobenzone, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60289-236
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone1.5 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.5 g  in 50 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene1.355 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
1,2-Hexanediol (UNII: TR046Y3K1G)  
Alanine (UNII: OF5P57N2ZX)  
Allantoin (UNII: 344S277G0Z)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Water (UNII: 059QF0KO0R)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
Benzyl Alcohol (UNII: LKG8494WBH)  
.Beta.-Sitosterol (UNII: S347WMO6M4)  
Levomenol (UNII: 24WE03BX2T)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Cetearyl Olivate (UNII: 58B69Q84JO)  
Cetyl Palmitate (UNII: 5ZA2S6B08X)  
Cetyl Phosphate (UNII: VT07D6X67O)  
Chinese Cinnamon (UNII: WS4CQ062KM)  
Commiphora Madagascariensis Resin (UNII: WCM0X628RY)  
Creatine (UNII: MU72812GK0)  
Cucumber (UNII: YY7C30VXJT)  
Cyclomethicone (UNII: NMQ347994Z)  
Dehydroacetic Acid (UNII: 2KAG279R6R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Glycerin (UNII: PDC6A3C0OX)  
Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)  
Helianthus Annuus Sprout (UNII: 4P26HG1S5W)  
Isostearyl Isostearate (UNII: IV0Z586Z4Y)  
Magnesium Aspartate (UNII: R17X820ROL)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Prickly Pear Fruit (UNII: 18V8PAQ629)  
Peg-40 Stearate (UNII: ECU18C66Q7)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Porphyra Umbilicalis (UNII: 14AN0J70WO)  
Propanediol (UNII: 5965N8W85T)  
Propylene Carbonate (UNII: 8D08K3S51E)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Invert Sugar (UNII: ED959S6ACY)  
Salicylic Acid (UNII: O414PZ4LPZ)  
Sanguisorba Officinalis Root (UNII: 4NYV2HT01X)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Sorbitan Olivate (UNII: MDL271E3GR)  
Sorbitan Monopalmitate (UNII: 77K6Z421KU)  
Sorbitan Tristearate (UNII: 6LUM696811)  
Squalene (UNII: 7QWM220FJH)  
.alpha.-tocopherol (UNII: H4N855PNZ1)  
Urea (UNII: 8W8T17847W)  
Xanthan Gum (UNII: TTV12P4NEE)  
Ginger (UNII: C5529G5JPQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60289-236-241 in 1 CARTON02/01/201308/01/2019
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/201308/01/2019
Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)

Revised: 9/2019
Document Id: 50bc0ac8-b455-430e-a774-e609160e6db2
Set id: 9930ea70-a5b9-4b94-a27f-2c88279c4fbf
Version: 2
Effective Time: 20190911
 
AHAVA Dead Sea Laboratories Ltd