AHAVA EXTREME DAILY FIRMNESS AND PROTECTION BROAD SPECTRUM SPF30- homosalate, octisalate, avobenzone, ensulizole, and octocrylene lotion

AHAVA Extreme Daily Firmness And Protection Broad Spectrum SPF30 by

Drug Labeling and Warnings

AHAVA Extreme Daily Firmness And Protection Broad Spectrum 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 2.84%	sunscreens
Ensulizole 2%	sunscreens
Homosalate 7%	sunscreens
Octisalate 5%	sunscreens
Octocrylene 0.76%	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), Glycerin, Caprylyl Methicone, C15-19 Alkane, Cellulose Acetate, Cetyl Alcohol, Oryza Sativa (Rice) Bran Oil, Saccharide Isomerate, Galactoarabinan, Glyceryl Stearate, Phenoxyethanol, Aminomethyl Propanol, Boron Nitride, Dimethicone, Butylene Glycol, PEG-75 Stearate, Caprylyl Glycol, Parfum (Fragrance), Pinene, Linalyl Acetate, Linalool, Limonene, Juniperus Virginiana Oil, Geraniol, Coumarin, Citrus Aurantium Peel Oil, Citronellol, Alpha Isomethyl Ionone, Steareth-20, Chlorphenesin, Ceteth-20, Sclerotium Gum, Disodium EDTA, Xanthan Gum, Dimethiconol, Helianthus Annuus (Sunflower ) Seed Oil, Sodium Lactate, Carbomer, Citric Acid, Sodium Citrate, Polysorbate 20, Simmondsia Chinensis (Jojoba) Seed Oil, Folic Acid, Sodium Benzoate, Potassium Sorbate, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Cetraria Islandica (Iceland Moss) Extract, Allantoin, Tocopherol (Vitamin E), Lycium Barbarum (Tibetian Goji Berry) Fruit Extract, Phoenix Dactylifera (Date) Fruit Extract, Dunaliella Salina (Dead Sea Alga) Extract, 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 Bottle Carton

AHAVA

Extreme Lotion
Daily Firmness
& Protection
Broad Spectrum
SPF 30

FIRMING

INGREDIENTS AND APPEARANCE

AHAVA EXTREME DAILY FIRMNESS AND PROTECTION BROAD SPECTRUM SPF30 
homosalate, octisalate, avobenzone, ensulizole, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	3.5 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	2.5 g  in 50 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	1.42 g  in 50 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	1 g  in 50 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.38 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
C15-19 Alkane (UNII: CI87N1IM01)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Cetyl Alcohol (UNII: 936JST6JCN)
Rice Bran Oil (UNII: LZO6K1506A)
Saccharide Isomerate (UNII: W8K377W98I)
Cellulose Acetate (UNII: 3J2P07GVB6)
CETRARIA ISLANDICA WHOLE (UNII: BJ7YPN79A1)
Allantoin (UNII: 344S277G0Z)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
Date (UNII: H3O7QI5HY7)
Folic Acid (UNII: 935E97BOY8)
Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)
Palmitoyl Tripeptide-1 (UNII: RV743D216M)
Galactoarabinan (UNII: SL4SX1O487)
Sunflower Oil (UNII: 3W1JG795YI)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Aminomethylpropanol (UNII: LU49E6626Q)
Boron Nitride (UNII: 2U4T60A6YD)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Ceteth-20 (UNII: I835H2IHHX)
Steareth-20 (UNII: L0Q8IK9E08)
Caprylyl Glycol (UNII: 00YIU5438U)
PEG-75 Stearate (UNII: OT38R0N74H)
Chlorphenesin (UNII: I670DAL4SZ)
Xanthan Gum (UNII: TTV12P4NEE)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
Betasizofiran (UNII: 2X51AD1X3T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Geraniol (UNII: L837108USY)
.Beta.-Citronellol, (R)- (UNII: P01OUT964K)
Coumarin (UNII: A4VZ22K1WT)
Limonene, (+)- (UNII: GFD7C86Q1W)
Linalool, (+/-)- (UNII: D81QY6I88E)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Polysorbate 20 (UNII: 7T1F30V5YH)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
Sodium Lactate (UNII: TU7HW0W0QT)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-305-24	1 in 1 CARTON	01/25/2024
1		50 mL in 1 BOTTLE, GLASS; 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	01/25/2024

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)