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

EXTREME by

Drug Labeling and Warnings

EXTREME 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 [2.99%]	sunscreens
Ensulizole [2%]	sunscreens
Homosalate [7%]	sunscreens
Octisalate [5%]	sunscreens
Octocrylene [0.86%]	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), Glycerin, C15-19 Alkane, Caprylyl Methicone, Cetyl Alcohol, Oryza Sativa (Rice) Bran Oil, Saccharide Isomerate, Cellulose Acetate, Maris Aqua (Dead Sea Water), Dunaliella Salina (Dead Sea Alga) Extract, Cetraria Islandica (Iceland Moss) Extract, Allantoin, Lycium Barbarum (Tibetian GojiBerry) Fruit Extract, Tocopherol (Vitamin E), Phoenix Dactylifera (Date) Fruit Extract, Folic Acid, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Galactoarabinan, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Stearate, Phenoxyethanol, Aminomethyl Propanol, Boron Nitride, Dimethicone, Butylene Glycol, Ceteth-20, Steareth-20, Caprylyl Glycol, PEG-75 Stearate, Chlorphenesin, Xanthan Gum, Disodium EDTA, Hydrogenated Polydecene, Dimethiconol, Sclerotium Gum, Lysolecithin, Pullulan, Carbomer, Parfum (Fragrance), Geraniol, Citronellol, Coumarin, Alpha Isomethyl Ionone, Limonene, Linalool, Citric Acid, Sodium Citrate, Polysorbate 20, Potassium Sorbate, Sodium Benzoate.

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

AHAVA

TIME TO REVITALIZE
EXTREME LOTION
DAILY FIRMNESS &
PROTECTION
BROAD SPECTRUM SPF 30

50 ml e 1.7 fl.oz

INGREDIENTS AND APPEARANCE

EXTREME   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: 60289-285
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	1.495 g  in 50 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	1 g  in 50 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.43 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 Subsp. Islandica (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 (550 MW) (UNII: U333RI6EB7)
Betasizofiran (UNII: 2X51AD1X3T)
Pullulan (UNII: 8ZQ0AYU1TT)
Carboxypolymethylene (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)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-285-24	1 in 1 CARTON	05/15/2019
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 NOT FINAL	part352	05/15/2019

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)