APPLE OF SODOM DEEP WRINKLE BROAD SPECTRUM SPF30- avobenzone, ensulizole, homosalate, octisalate, and octocrylene lotion

APPLE OF SODOM by

Drug Labeling and Warnings

APPLE OF SODOM 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 (1%)	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), C15-19 Alkane, Glycerin, Caprylyl Methicone, Oryza Sativa (Rice) Bran Oil, Caprylic/Capric Triglyceride, Saccharide Isomerate, Cellulose Acetate, Cetyl Alcohol, Glyceryl Stearate, Cetearyl Alcohol, Ectoin, Allantoin, Acmella Oleracea Extract, Maris Aqua (Dead Sea Water), Spilanthes Acmella Flower Extract, Calotropis Procera Callus (Apple of Sodom) Extract, Phoenix Dactylifera (Date) Fruit Extract, Dunaliella Salina (Dead Sea Alga) Extract, Galactoarabinan, Tripeptide-3, Dimethicone, Phenoxyethanol, Propanediol, PEG-75 Stearate, Benzotriazolyl Dodecyl p-Cresol, Boron Nitride, Aminomethyl Propanol, Parfum (Fragrance), Hexyl Cinnamal, Linalool, Limonene, Geraniol, Ceteth-20, Steareth-20, Xanthan Gum, Butylene Glycol, Dimethiconol, Potassium Sorbate, Disodium EDTA, Sclerotium Gum, Hydrogenated Polydecene, Lysolecithin, Chlorphenesin, Pullulan, Caprylyl Glycol, Didecyldimonium Chloride, Citric Acid, Sodium Citrate, Sodium Benzoate.

Other information

Protect the product in this container from excessive heat and direct sun

Questions or comments

Call toll free 1-800-366-7254

SPL UNCLASSIFIED SECTION

Manufactured by
AHAVA Dead Sea Laboratories Ltd. Airport City, 7019900 Israel

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

AHAVA

DEEP WRINKLE LOTION
BROAD SPECTRUM SPF30

APPLE OF SODOM

Paraben Free Clinically Proven
Registered by the Vegan Society

50 ml e 1.7 fl.oz

INGREDIENTS AND APPEARANCE

APPLE OF SODOM   DEEP WRINKLE BROAD SPECTRUM SPF30
avobenzone, ensulizole, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-286
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	1.495 g  in 50 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	0.5 g  in 50 mL
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
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.43 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
C15-19 Alkane (UNII: CI87N1IM01)
Glycerin (UNII: PDC6A3C0OX)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Rice Bran Oil (UNII: LZO6K1506A)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Saccharide Isomerate (UNII: W8K377W98I)
Cellulose Acetate (UNII: 3J2P07GVB6)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Ectoine (UNII: 7GXZ3858RY)
Allantoin (UNII: 344S277G0Z)
Acmella Oleracea Flowering Top (UNII: 1O11RD9U53)
Acmella Oleracea Flower (UNII: 2794N5KM0K)
Date (UNII: H3O7QI5HY7)
Galactoarabinan (UNII: SL4SX1O487)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propanediol (UNII: 5965N8W85T)
PEG-75 Stearate (UNII: OT38R0N74H)
Benzotriazolyl Dodecyl p-Cresol (UNII: 298PX4M11X)
Boron Nitride (UNII: 2U4T60A6YD)
Aminomethylpropanol (UNII: LU49E6626Q)
.Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)
Linalool, (+/-)- (UNII: D81QY6I88E)
Limonene, (+)- (UNII: GFD7C86Q1W)
Geraniol (UNII: L837108USY)
Ceteth-20 (UNII: I835H2IHHX)
Steareth-20 (UNII: L0Q8IK9E08)
Xanthan Gum (UNII: TTV12P4NEE)
Butylene Glycol (UNII: 3XUS85K0RA)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Betasizofiran (UNII: 2X51AD1X3T)
Chlorphenesin (UNII: I670DAL4SZ)
Pullulan (UNII: 8ZQ0AYU1TT)
Caprylyl Glycol (UNII: 00YIU5438U)
Didecyldimonium Chloride (UNII: JXN40O9Y9B)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Sodium Benzoate (UNII: OJ245FE5EU)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-286-24	1 in 1 CARTON	04/01/2020
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	04/01/2020

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)