AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15- avobenzone, octisalate, and octocrylene cream

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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone [3%]	sunscreen
Octisalate [5%]	sunscreen
Octocrylene [2.7%]	sunscreen

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 Center right away

Directions

• apply liberally and evenly to clean face 15 minutes before sun exposure
• use a water-resistant sunscreen if swimming or sweating.
• reapply at least every 2 hours.
• 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

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

Other information

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

Questions or comments

Call toll free 1-800-366-7254

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

AHAVA

TIME TO ENERGIZE

AGE CONTROL
MOISTURIZING CREAM
BROAD SPECTRUM SPF15

MEN

50 ml e 1.7 fl.oz

INGREDIENTS AND APPEARANCE

AHAVA ACTIVE DEADSEA MINERALS   TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Glycerin (UNII: PDC6A3C0OX)
Peg-40 Stearate (UNII: ECU18C66Q7)
Sorbitan Tristearate (UNII: 6LUM696811)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Dimethicone (UNII: 92RU3N3Y1O)
Sorbitan Olivate (UNII: MDL271E3GR)
Cetearyl Olivate (UNII: 58B69Q84JO)
Cyclomethicone (UNII: NMQ347994Z)
Phenoxyethanol (UNII: HIE492ZZ3T)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
Sorbitan Monopalmitate (UNII: 77K6Z421KU)
Propylene Carbonate (UNII: 8D08K3S51E)
Quaternium-18 Hectorite (UNII: IIS3YBV1XX)
Ethylhexylglycerin (UNII: 147D247K3P)
Caprylyl Glycol (UNII: 00YIU5438U)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cetyl Phosphate (UNII: VT07D6X67O)
Isostearyl Isostearate (UNII: IV0Z586Z4Y)
Cucumber (UNII: YY7C30VXJT)
Alanine (UNII: OF5P57N2ZX)
Creatine (UNII: MU72812GK0)
Glycine (UNII: TE7660XO1C)
Magnesium Aspartate (UNII: R17X820ROL)
Invert Sugar (UNII: ED959S6ACY)
Urea (UNII: 8W8T17847W)
Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)
Propanediol (UNII: 5965N8W85T)
Chinese Cinnamon (UNII: WS4CQ062KM)
Sanguisorba Officinalis Root (UNII: 4NYV2HT01X)
Levomenol (UNII: 24WE03BX2T)
Xanthan Gum (UNII: TTV12P4NEE)
Allantoin (UNII: 344S277G0Z)
Ginger (UNII: C5529G5JPQ)
Ginkgo (UNII: 19FUJ2C58T)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Asian Ginseng (UNII: CUQ3A77YXI)
Panthenol (UNII: WV9CM0O67Z)
Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)
Ascorbyl Palmitate (UNII: QN83US2B0N)
.Beta.-Sitosterol (UNII: S347WMO6M4)
Propylene Glycol (UNII: 6DC9Q167V3)
Squalene (UNII: 7QWM220FJH)
Tocopherol (UNII: R0ZB2556P8)
Porphyra Umbilicalis (UNII: 14AN0J70WO)
Prickly Pear Fruit (UNII: 18V8PAQ629)
Helianthus Annuus Sprout (UNII: 4P26HG1S5W)
Salicylic Acid (UNII: O414PZ4LPZ)
Commiphora Madagascariensis Resin (UNII: WCM0X628RY)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
Benzyl Salicylate (UNII: WAO5MNK9TU)
Coumarin (UNII: A4VZ22K1WT)
Eugenol (UNII: 3T8H1794QW)
Linalool, (+/-)- (UNII: D81QY6I88E)
Povidone K30 (UNII: U725QWY32X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LIMONENE, (-)- (UNII: 47MAJ1Y2NE)
FARNESOL, (2E,6Z)- (UNII: 413TVZ4919)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
Lecithin, Soybean (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-282-24	1 in 1 CARTON	07/25/2013
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	07/25/2013

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)