AHAVA ACTIVE DEADSEA MINERALS AGE CONTROL EVEN TONE MOISTURIZER BROAD SPECTRUM SPF20- avobenzone, octisalate, homosalate, 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]

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Drug Facts

Active ingredients

Butyl Methoxydibenzoylmethane [3%]
Ethylhexyl Salicylate [5%]
Homosalate [5%]
Octocrylene [2.7%]

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
• apply daily for a clearer, brighter complexion
• 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

Aloe Barbadensis Leaf Juice, Aminomethyl Propanediol, Aqua (Mineral Spring Water), Aqua (Water), Ascorbic Acid, Ascorbyl Glucoside, Benzotriazolyl Dodecyl p-Cresol, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Citrus Reticulata (Tangerine) Peel Extract, Commiphora Abyssinica Resin Extract, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Disodium EDTA, Disodium Lauriminodipropionate Tocopheryl Phospates, Dunaliella Salina Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Olive Oil Cetyl Esters, Hydrogenated Palm Glycerides, Hydrogenated Polydecene, Hydroxyapatite, Maris Aqua (Dead Sea Water), Melissa Officinalis Leaf Extract, Methylpropanediol, Myricetin, Octyldodecyl Neopentanoate, Oenothera Biennis (Evening Primrose) Oil, Opuntia Ficus- Indica Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Parfum (Fragrance), PEG-100 Stearate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocin, Pseudoalteromonas Ferment Extract, Pentylene Glycol, Pentylene Glycol, Phenoxyethanol, Phoenix Dactylifera (Date) Seed Extract, Polyglycerine-3, Polyglyceryl-3 polyricinoleate, Porphyra Umbilicalis Extract, Potassium Cetyl Phosphate, Propylene Glycol, Salicylic Acid, Scutellaria Baicalensis Extract, Sodium Citrate, Sodium Lactate, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl (Vitamin E) Acetate, Tris (Tetramethyl Hydroxypiperidinol) Citrate, Undecylcrylene Dimethicone, Xanthan Gum, Zinc PCA, Zizyphus Jujuba Fruit 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

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

AHAVA

ACTIVE DEADSEA MINERALS

TIME TO SMOOTH

AGE CONTROL EVEN TONE MOISTURIZER

BROAD SPECTRUM SPF20

50 ml e 1.7 fl.oz

INGREDIENTS AND APPEARANCE

AHAVA ACTIVE DEADSEA MINERALS   AGE CONTROL EVEN TONE MOISTURIZER BROAD SPECTRUM SPF20
avobenzone, octisalate, homosalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-247
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	1.5 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	2.5 g  in 50 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	2.5 g  in 50 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	1.35 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Aminomethyl Propanediol (UNII: CZ7BU4QZJZ)
Water (UNII: 059QF0KO0R)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Ascorbyl Glucoside (UNII: 2V52R0NHXW)
Benzotriazolyl Dodecyl p-Cresol (UNII: 298PX4M11X)
Butylene Glycol (UNII: 3XUS85K0RA)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Tangerine Peel (UNII: JU3D414057)
Commiphora Madagascariensis Resin (UNII: WCM0X628RY)
Cucumber (UNII: YY7C30VXJT)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium (UNII: 7FLD91C86K)
Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)
Dunaliella Salina (UNII: F4O1DKI9A6)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Sunflower Oil (UNII: 3W1JG795YI)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Tribasic Calcium Phosphate (UNII: 91D9GV0Z28)
Melissa Officinalis Leaf (UNII: 50D2ZE9219)
Methylpropanediol (UNII: N8F53B3R4R)
Myricetin (UNII: 76XC01FTOJ)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Evening Primrose Oil (UNII: 3Q9L08K71N)
Prickly Pear Fruit (UNII: 18V8PAQ629)
Helianthus Annuus Sprout (UNII: 4P26HG1S5W)
PEG-100 Stearate (UNII: YD01N1999R)
Pentylene Glycol (UNII: 50C1307PZG)
Phenoxyethanol (UNII: HIE492ZZ3T)
Phoenix Dactylifera Seed (UNII: 73NE6T0Q00)
Porphyra Umbilicalis (UNII: 14AN0J70WO)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Propylene Glycol (UNII: 6DC9Q167V3)
Salicylic Acid (UNII: O414PZ4LPZ)
Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)
Sodium Citrate (UNII: 1Q73Q2JULR)
Sodium Lactate (UNII: TU7HW0W0QT)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tris(Tetramethylhydroxypiperidinol) Citrate (UNII: 7NW772I64Y)
Xanthan Gum (UNII: TTV12P4NEE)
Zinc Pidolate (UNII: C32PQ86DH4)
Jujube Fruit (UNII: G55HNL2C70)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-247-24	1 in 1 CARTON
1		50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/01/2013

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)