AHAVA PROTECTING BODY SPF30- avobenzone, ensulizole, homosalate, octisalate, and octocrylene lotion

AHAVA Protecting Body SPF30 by

Drug Labeling and Warnings

AHAVA Protecting Body SPF30 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 INGREDIENT

Active ingredients	Purpose
Avobenzone (3%)	sunscreens
Ensulizole (2%)	sunscreens
Homosalate (7%)	sunscreens
Octisalate (5%)	sunscreens
Octocrylene (0.87%)	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 Center 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

Aqua (Mineral Spring WaterC12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cellulose Acetate, PEG-100 Stearate, Glyceryl Stearate, Glycerin, Potassium Cetyl Phosphate, Galactoarabinan, Phenoxyethanol, Hydrogenated Palm Glycerides, Aminomethyl Propanol, Erythritol, Dimethicone, Parfum (Fragrance), Limonene, Linalool, Geraniol, Citronellol, Xanthan Gum, Chlorphenesin, Dimethiconol, Caprylyl Glycol, Didecyldimonium Chloride, Gluconolactone, Sodium Citrate, Sodium Hydroxide, Sodium Benzoate, Potassium Sorbate, Homarine HCl, Sorbic Acid, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Allantoin, Acacia Senegal Gum, Coffea Arabica (Coffee) Seed Extract, Euterpe Oleracea (Acai) Fruit Extract, Maris Aqua (Dead Sea Water/Osmoter).

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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Manufactured by AHAVA Dead Sea Laboratories, Dead Sea,
Israel, 8698000

PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton

AHAVA

Protecting
Body Lotion

Broad Spectrum
SPF 30
PA +++

BODY ESSENTIAL
HYDRATION

INGREDIENTS AND APPEARANCE

AHAVA PROTECTING BODY SPF30 
avobenzone, ensulizole, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-299
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	4.5 g  in 150 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	3 g  in 150 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10.5 g  in 150 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	7.5 g  in 150 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	1.305 g  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cellulose Acetate (UNII: 3J2P07GVB6)
PEG-100 Stearate (UNII: YD01N1999R)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Glycerin (UNII: PDC6A3C0OX)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Galactoarabinan (UNII: SL4SX1O487)
Phenoxyethanol (UNII: HIE492ZZ3T)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Aminomethylpropanol (UNII: LU49E6626Q)
Erythritol (UNII: RA96B954X6)
Dimethicone (UNII: 92RU3N3Y1O)
Limonene, (+)- (UNII: GFD7C86Q1W)
Linalool, (+/-)- (UNII: D81QY6I88E)
Geraniol (UNII: L837108USY)
.Beta.-Citronellol, (R)- (UNII: P01OUT964K)
Xanthan Gum (UNII: TTV12P4NEE)
Chlorphenesin (UNII: I670DAL4SZ)
Caprylyl Glycol (UNII: 00YIU5438U)
Didecyldimonium Chloride (UNII: JXN40O9Y9B)
Gluconolactone (UNII: WQ29KQ9POT)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Benzoate (UNII: OJ245FE5EU)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Homarine Hydrochloride (UNII: 8866LNG61N)
Sorbic Acid (UNII: X045WJ989B)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Allantoin (UNII: 344S277G0Z)
Acacia (UNII: 5C5403N26O)
Arabica Coffee Bean (UNII: 3SW678MX72)
Acai (UNII: 46AM2VJ0AW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-299-30	1 in 1 CARTON	05/12/2022
1		150 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	05/12/2022

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)