AHAVA PROTECTING MOISTURIZING SPF50- avobenzone, ensulizole, homosalate, octisalate, and octocrylene lotion

AHAVA Protecting Moisturizing SPF50 by

Drug Labeling and Warnings

AHAVA Protecting Moisturizing SPF50 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 2.84%	sunscreens
Ensulizole 3%	sunscreens
Homosalate 7.3%	sunscreens
Octisalate 5%	sunscreens
Octocrylene 9.89%	sunscreens

Uses

• helps prevent sunburn.

Warnings

For external use only.

Do not use on damaged or broken skin.

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

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

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

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

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

INACTIVE INGREDIENTS

Aqua (Mineral Spring Water), Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, C15-19 Alkane, Propanediol, Dimethyl Capramide, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Tapioca Starch, Cellulose Acetate, Coco-Caprylate/Caprate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-100 Stearate, Aminomethyl Propanol, PEG-40 Stearate, Phenoxyethanol, Hydrogenated Palm Glycerides, Erythritol, Parfum (Fragrance), Linalyl Acetate, Hexamethylindanopyran, Disodium Cetearyl Sulfosuccinate, Gluconolactone, Xanthan Gum, Chlorphenesin, Sodium Citrate, Sodium Hydroxide, Sodium Benzoate, Caprylyl Glycol, Didecyldimonium Chloride, Potassium Sorbate, Homarine HCl, Citric Acid, Bacillus Ferment, Allantoin, Maris Aqua (Dead Sea Water/Osmoter).

Other information

• protect this product from excessive heat and direct sun

Questions or comments

Call toll free 1-800-366-7254

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

AHAVA

Protecting
Moisturizing Lotion
Broad Spectrum
SPF 50

PA ++++

HYDRATE

INGREDIENTS AND APPEARANCE

AHAVA PROTECTING MOISTURIZING SPF50 
avobenzone, ensulizole, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.0284 g  in 1 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	0.03 g  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.073 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.0989 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Safflower Oil (UNII: 65UEH262IS)
Glycerin (UNII: PDC6A3C0OX)
C15-19 Alkane (UNII: CI87N1IM01)
Propanediol (UNII: 5965N8W85T)
Dimethyl Capramide (UNII: O29Y6X2JEZ)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Starch, Tapioca (UNII: 24SC3U704I)
Cellulose Acetate (UNII: 3J2P07GVB6)
Cocoyl Caprylocaprate (UNII: 8D9H4QU99H)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
PEG-100 Stearate (UNII: YD01N1999R)
Aminomethylpropanol (UNII: LU49E6626Q)
PEG-40 Monostearate (UNII: ECU18C66Q7)
Phenoxyethanol (UNII: HIE492ZZ3T)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Erythritol (UNII: RA96B954X6)
Linalyl Acetate (UNII: 5K47SSQ51G)
Hexamethylindanopyran (UNII: 14170060AT)
Gluconolactone (UNII: WQ29KQ9POT)
Xanthan Gum (UNII: TTV12P4NEE)
Chlorphenesin (UNII: I670DAL4SZ)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Benzoate (UNII: OJ245FE5EU)
Caprylyl Glycol (UNII: 00YIU5438U)
Didecyldimonium Chloride (UNII: JXN40O9Y9B)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Homarine Hydrochloride (UNII: 8866LNG61N)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Allantoin (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-307-24	1 in 1 CARTON	03/15/2025
1		50 mL in 1 BOTTLE; 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	03/15/2025

Labeler - AHAVA - Dead Sea Laboratories Ltd (600056907)