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 (2.998%)	sunscreens
Ensolizole (2%)	sunscreens
Homosalate (10%)	sunscreens
Octisalate (5%)	sunscreens
Octocrylene (10%)	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 Water), Carthamus Tinctorius (Safflower) Oleosomes, Glycerin, C15-19 Alkane, Propanediol (Corn derived), Tapioca Starch, Coco-Caprylate/Caprate, Cellulose Acetate, PEG-100 Stearate, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-40 Stearate, Dimethyl Capramide, Cetearyl Alcohol, Phenoxyethanol, Aminomethyl Propanol, Hydrogenated Palm Glycerides, Erythritol, Parfum (Fragrance), Disodium Cetearyl Sulfosuccinate, Gluconolactone, Chlorphenesin, Sodium Citrate, Xanthan Gum, Sodium Hydroxide, Sodium Benzoate, Caprylyl Glycol, Didecyldimonium Chloride, Potassium Sorbate, Homarine HCl, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Allantoin, Bacillus Ferment, Maris Aqua (Dead Sea Water/Osmoter).

SPL UNCLASSIFIED SECTION

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

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: 60289-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.02998 g  in 1 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	0.02 g  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.1 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)
Glycerin (UNII: PDC6A3C0OX)
C15-19 Alkane (UNII: CI87N1IM01)
Starch, Tapioca (UNII: 24SC3U704I)
Cocoyl Caprylocaprate (UNII: 8D9H4QU99H)
Cellulose Acetate (UNII: 3J2P07GVB6)
PEG-100 Stearate (UNII: YD01N1999R)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
PEG-40 Stearate (UNII: ECU18C66Q7)
Dimethyl Capramide (UNII: O29Y6X2JEZ)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Phenoxyethanol (UNII: HIE492ZZ3T)
Aminomethylpropanol (UNII: LU49E6626Q)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Erythritol (UNII: RA96B954X6)
Gluconolactone (UNII: WQ29KQ9POT)
Chlorphenesin (UNII: I670DAL4SZ)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Benzoate (UNII: OJ245FE5EU)
Caprylyl Glycol (UNII: 00YIU5438U)
Didecyldimonium Chloride (UNII: JXN40O9Y9B)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Homarine Hydrochloride (UNII: 8866LNG61N)
Aloe (UNII: V5VD430YW9)
Allantoin (UNII: 344S277G0Z)
Sodium Chloride (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-300-24	1 in 1 CARTON	06/06/2022
1		50 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	06/06/2022

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)