AHAVA BRIGHTENING BROAD SPECTRUM SPF 20- avobenzone, homosalate, octisalate, and octocrylene cream

AHAVA by

Drug Labeling and Warnings

AHAVA 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 3%	sunscreens
Homosalate 7%	sunscreens
Octisalate 5%	sunscreens
Octocrylene 2.74%	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), Butyloctyl Salicylate, Dimethicone, Glycerin, Octyldodecyl Neopentanoate, Niacinamide, Ascorbyl Glucoside (Vitamin C derivative), Styrene/Acrylates Copolymer, C12-15 Alkyl Benzoate, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Stearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Sodium Citrate, Potassium Cetyl Phosphate, Hydrogenated Olive Oil Cetyl Esters, Phenoxyethanol, Hydrogenated Palm Glycerides, Aminomethyl Propanol, Cetearyl Alcohol, Benzotriazolyl Dodecyl p-Cresol, Parfum (Fragrance), Xanthan Gum, Ethylhexylglycerin, Butylene Glycol, Diisobutyl Adipate, Citric Acid, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Glycine Soja (Soybean) Oil, Ascorbic Acid, Ascorbyl Palmitate, Pseudoalteromonas Ferment Extract, Propylene Glycol, Lecithin, Hydrogenated Vegetable Glycerides Citrate, Sodium Benzoate, Potassium Sorbate, Beta-Sitosterol, Squalene (Phytosqualene), Helianthus Annuus (Sunflower) Sprout Extract, Lactic Acid, Commiphora Abyssinica Resin Extract, Sodium Hydroxide, Porphyra Umbilicalis Extract, Tocopherol (Vitamin E), Opuntia Ficus-Indica Fruit Extract, Zizyphus Jujuba Fruit Extract, Camellia Sinensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Calendula Officinalis Flower Extract, Rumex Occidentalis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Salicylic Acid, Tocopheryl (Vitamin E) Acetate, Phoenix Dactylifera (Date) Fruit Extract, Dunaliella Salina (Dead Sea Alga) 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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

AHAVA

Brightening Cream
Broad Spectrum SPF 20

EVEN TONE

INGREDIENTS AND APPEARANCE

AHAVA   BRIGHTENING BROAD SPECTRUM SPF 20
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	70 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Dimethicone (UNII: 92RU3N3Y1O)
Glycerin (UNII: PDC6A3C0OX)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Niacinamide (UNII: 25X51I8RD4)
Ascorbyl Glucoside (UNII: 2V52R0NHXW)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Monostearate (UNII: YD01N1999R)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Hydrogenated Olive Oil Cetyl Esters (UNII: AUR5S128JM)
Phenoxyethanol (UNII: HIE492ZZ3T)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Aminomethylpropanol (UNII: LU49E6626Q)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Benzotriazolyl Dodecyl p-Cresol (UNII: 298PX4M11X)
Xanthan Gum (UNII: TTV12P4NEE)
Ethylhexylglycerin (UNII: 147D247K3P)
Butylene Glycol (UNII: 3XUS85K0RA)
Diisobutyl Adipate (UNII: 8OPY05ZY7S)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Soybean Oil (UNII: 241ATL177A)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Benzoate (UNII: OJ245FE5EU)
Potassium Sorbate (UNII: 1VPU26JZZ4)
.Beta.-Sitosterol (UNII: S347WMO6M4)
Squalene (UNII: 7QWM220FJH)
Helianthus Annuus Sprout (UNII: 4P26HG1S5W)
Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)
Commiphora Madagascariensis Resin (UNII: WCM0X628RY)
Sodium Hydroxide (UNII: 55X04QC32I)
Porphyra Umbilicalis (UNII: 14AN0J70WO)
.Alpha.-tocopherol (UNII: H4N855PNZ1)
Prickly Pear Fruit (UNII: 18V8PAQ629)
Jujube Fruit (UNII: G55HNL2C70)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Cucumber (UNII: YY7C30VXJT)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Jojoba Oil (UNII: 724GKU717M)
Salicylic Acid (UNII: O414PZ4LPZ)
.Alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
Dunaliella Salina (UNII: F4O1DKI9A6)
Date (UNII: H3O7QI5HY7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-303-24	1 in 1 CARTON	02/12/2024
1		50 mL in 1 JAR; 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	02/12/2024

Labeler - AHAVA - Dead Sea Laboratories Ltd (600056907)