AHAVA AGE PERFECTING BROAD SPECTRUM SPF15- avobenzone, octisalate, and octocrylene cream

AHAVA AGE PERFECTING by

Drug Labeling and Warnings

AHAVA AGE PERFECTING 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 ingredients

Avobenzone [3%]
Octisalate [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 15 minutes before sun exposure
• children under 6 months of age: Ask a doctor
• Use a water-resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours

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), Glycerin, Isohexadecane, Dimethicone, Butyloctyl Salicylate, Glyceryl Stearate, C12-15 Alkyl Benzoate, Peg-40 Stearate, Octyldodecyl Neopentanoate, Sodium Lactate, Stearyl Alcohol, Hydrogenated Olive Oil Cetyl Esters, Sorbitan Tristearate, Ascorbyl Glucoside, Maris Aqua (Dead Sea Water), Phenoxyethanol, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice, Aminomethyl Propanediol, Butylene Glycol, Zizyphus Jujuba Fruit Extract, Salicylic Acid, Parfum (Fragrance), Niacinamide, Xanthan Gum, Dunaliella Salina Extract, Hydrogenated Polydecene, Caprylyl Glycol, Phoenix Dactylifera (DATE) Fruit Extract, Chlorphenesin, Dictyopteris Membranacea Extract, Sodium Citrate, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Ascorbic Acid, Melissa Officinalis Leaf Extract, Polyglyceryl-3 polyricinoleate, Methylpropanediol, Citrus Reticulata (Tangerine) Peel Extract, Polyglycerine-3, Pentylene Glycol, Myricetin, Scutellaria Baicalensis Extract, Porphyra Umbilicalis Extract, Opuntia Ficus-Indica Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocin, Pseudoalteromonas Ferment Extract, Commiphora Abyssinica Resin Extract, Citric Acid, Diisobutyl Adipate.

Other information

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

Questions or comments

Call toll free 1-800-366-7254

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

AHAVA
ACTIVE DEADSEA MINERALS

TIME TO SMOOTH
AGE PERFECTING HAND CREAM
BROAD SPECTRUM SPF15
dark spot correction

75 ml e 2.5 fl.oz

INGREDIENTS AND APPEARANCE

AHAVA AGE PERFECTING  BROAD SPECTRUM SPF15
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2.25 g  in 75 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	3.75 g  in 75 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.05 g  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Isohexadecane (UNII: 918X1OUF1E)
Dimethicone (UNII: 92RU3N3Y1O)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Peg-40 Stearate (UNII: ECU18C66Q7)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Sodium Lactate (UNII: TU7HW0W0QT)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Sorbitan Tristearate (UNII: 6LUM696811)
Ascorbyl Glucoside (UNII: 2V52R0NHXW)
Phenoxyethanol (UNII: HIE492ZZ3T)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Aminomethyl Propanediol (UNII: CZ7BU4QZJZ)
Butylene Glycol (UNII: 3XUS85K0RA)
Jujube Fruit (UNII: G55HNL2C70)
Salicylic Acid (UNII: O414PZ4LPZ)
Niacinamide (UNII: 25X51I8RD4)
Xanthan Gum (UNII: TTV12P4NEE)
Dunaliella Salina (UNII: F4O1DKI9A6)
Caprylyl Glycol (UNII: 00YIU5438U)
Date (UNII: H3O7QI5HY7)
Chlorphenesin (UNII: I670DAL4SZ)
Dictyopteris Polypodioides (UNII: 83H6O5GR42)
Sodium Citrate (UNII: 1Q73Q2JULR)
Edetate Disodium (UNII: 7FLD91C86K)
Sunflower Oil (UNII: 3W1JG795YI)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Melissa Officinalis Leaf (UNII: 50D2ZE9219)
Polyglycerin-3 (UNII: 4A0NCJ6RD6)
Methylpropanediol (UNII: N8F53B3R4R)
Tangerine Peel (UNII: JU3D414057)
Pentylene Glycol (UNII: 50C1307PZG)
Myricetin (UNII: 76XC01FTOJ)
Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)
Porphyra Umbilicalis (UNII: 14AN0J70WO)
Prickly Pear Fruit (UNII: 18V8PAQ629)
Helianthus Annuus Sprout (UNII: 4P26HG1S5W)
Commiphora Madagascariensis Resin (UNII: WCM0X628RY)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Diisobutyl Adipate (UNII: 8OPY05ZY7S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-281-26	1 in 1 CARTON
1		75 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/15/2013

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)