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APPLE OF SODOM

APPLE OF SODOM Deep Wrinkle Lotion Broad Spectrum SPF30

Approved
Approval ID

6125b707-cdf5-430a-bb7a-85d67c1511ff

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 28, 2025

Manufacturers
FDA

AHAVA Dead Sea Laboratories Ltd

DUNS: 600056907

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone, Ensulizole, Homosalate, Octisalate, and Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60289-286
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Ensulizole, Homosalate, Octisalate, and Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 28, 2025
FDA Product Classification

INGREDIENTS (48)

AvobenzoneActive
Quantity: 1.495 g in 50 mL
Code: G63QQF2NOX
Classification: ACTIB
EnsulizoleActive
Quantity: 0.5 g in 50 mL
Code: 9YQ9DI1W42
Classification: ACTIB
HomosalateActive
Quantity: 3.5 g in 50 mL
Code: V06SV4M95S
Classification: ACTIB
OctisalateActive
Quantity: 2.5 g in 50 mL
Code: 4X49Y0596W
Classification: ACTIB
OctocryleneActive
Quantity: 0.43 g in 50 mL
Code: 5A68WGF6WM
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
C15-19 AlkaneInactive
Code: CI87N1IM01
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Caprylyl TrisiloxaneInactive
Code: Q95M2P1KJL
Classification: IACT
Rice Bran OilInactive
Code: LZO6K1506A
Classification: IACT
Medium-Chain TriglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
Saccharide IsomerateInactive
Code: W8K377W98I
Classification: IACT
Cellulose AcetateInactive
Code: 3J2P07GVB6
Classification: IACT
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
Cetostearyl AlcoholInactive
Code: 2DMT128M1S
Classification: IACT
EctoineInactive
Code: 7GXZ3858RY
Classification: IACT
AllantoinInactive
Code: 344S277G0Z
Classification: IACT
Acmella Oleracea Flowering TopInactive
Code: 1O11RD9U53
Classification: IACT
Acmella Oleracea FlowerInactive
Code: 2794N5KM0K
Classification: IACT
DateInactive
Code: H3O7QI5HY7
Classification: IACT
GalactoarabinanInactive
Code: SL4SX1O487
Classification: IACT
DimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
PhenoxyethanolInactive
Code: HIE492ZZ3T
Classification: IACT
PropanediolInactive
Code: 5965N8W85T
Classification: IACT
PEG-75 StearateInactive
Code: OT38R0N74H
Classification: IACT
Benzotriazolyl Dodecyl p-CresolInactive
Code: 298PX4M11X
Classification: IACT
Boron NitrideInactive
Code: 2U4T60A6YD
Classification: IACT
AminomethylpropanolInactive
Code: LU49E6626Q
Classification: IACT
.Alpha.-HexylcinnamaldehydeInactive
Code: 7X6O37OK2I
Classification: IACT
Linalool, (+/-)-Inactive
Code: D81QY6I88E
Classification: IACT
Limonene, (+)-Inactive
Code: GFD7C86Q1W
Classification: IACT
GeraniolInactive
Code: L837108USY
Classification: IACT
Ceteth-20Inactive
Code: I835H2IHHX
Classification: IACT
Steareth-20Inactive
Code: L0Q8IK9E08
Classification: IACT
Xanthan GumInactive
Code: TTV12P4NEE
Classification: IACT
Butylene GlycolInactive
Code: 3XUS85K0RA
Classification: IACT
Potassium SorbateInactive
Code: 1VPU26JZZ4
Classification: IACT
Edetate Disodium AnhydrousInactive
Code: 8NLQ36F6MM
Classification: IACT
BetasizofiranInactive
Code: 2X51AD1X3T
Classification: IACT
ChlorphenesinInactive
Code: I670DAL4SZ
Classification: IACT
PullulanInactive
Code: 8ZQ0AYU1TT
Classification: IACT
Caprylyl GlycolInactive
Code: 00YIU5438U
Classification: IACT
Didecyldimonium ChlorideInactive
Code: JXN40O9Y9B
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Sodium Citrate, Unspecified FormInactive
Code: 1Q73Q2JULR
Classification: IACT
Sodium BenzoateInactive
Code: OJ245FE5EU
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/28/2025

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/28/2025

Uses

  • helps prevent sunburn

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/28/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/28/2025

Active ingredients

Purpose

Avobenzone (2.99%)

sunscreens

Ensulizole (1%)

sunscreens

Homosalate (7%)

sunscreens

Octisalate (5%)

sunscreens

Octocrylene (0.86%)

sunscreens

WARNINGS SECTION

LOINC: 34071-1Updated: 7/28/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/28/2025

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 7/28/2025

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/28/2025

Other information

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/28/2025

Questions or comments

Call toll free 1-800-366-7254

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APPLE OF SODOM - FDA Drug Approval Details