FDA.reportPublic FDA data

Dead Sea Natural

Manufacturer
AHAVA Dead Sea Laboratories Ltd
Effective date
2023-11-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:01:58

Label at a glance#

ProductDead Sea Natural Face Moisturizer Broad Spectrum SPF 20
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure10 sections

Indications and uses

helps prevent sunburn

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone [3%]sunscreens
Homosalate [7%]sunscreens
Octisalate [5%]sunscreens
Octocrylene [2.7%]sunscreens

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For External Use Only

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and consult a doctor if rash or irritation develops and lasts

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical attention or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

AQUA (MINERAL SPRING WATER), BUTYLOCTYL SALICYLATE, DIMETHICONE, GLYCERIN, OCTYLDODECYL NEOPENTANOATE, NIACINAMIDE, ASCORBYL GLUCOSIDE (VITAMIN C DERIVATIVE), STYRENE/ACRYLATES COPOLYMER, C12-15 ALKYL BENZOATE, STEARYL ALCOHOL, PEG-100 STEARATE, GLYCERYL STEARATE, SODIUM CITRATE, POTASSIUM CETYL PHOSPHATE, HYDROGENATED OLIVE OIL CETYL ESTERS, PHENOXYETHANOL, HYDROGENATED PALM GLYCERIDES, AMINOMETHYL PROPANOL, CETEARYL ALCOHOL, BENZOTRIAZOLYL DODECYL P-CRESOL, SALICYLIC ACID, TOCOPHERYL (VITAMIN E) ACETATE, PARFUM (FRAGRANCE), XANTHAN GUM, ETHYLHEXYLGLYCERIN, HYDROGENATED POLYDECENE, DIISOBUTYL ADIPATE, BUTYLENE GLYCOL, CITRIC ACID, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, GLYCINE SOJA (SOYBEAN) OIL, HYDROGENATED VEGETABLE GLYCERIDES CITRATE, BETA-SITOSTEROL, ASCORBYL PALMITATE, PROPYLENE GLYCOL, LECITHIN, SODIUM BENZOATE, POTASSIUM SORBATE, SODIUM HYDROXIDE, LACTIC ACID, COMMIPHORA ABYSSINICA RESIN EXTRACT, OPUNTIA FICUS-INDICA FRUIT EXTRACT, SQUALENE (PHYTOSQUALENE), PORPHYRA UMBILICALIS EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, ZIZYPHUS JUJUBA FRUIT EXTRACT, PSEUDOALTEROMONAS FERMENT EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, TOCOPHEROL (VITAMIN E), ASCORBIC ACID, RUMEX OCCIDENTALIS EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, PHOENIX DACTYLIFERA (DATE) FRUIT EXTRACT, DUNALIELLA SALINA (DEAD SEA ALGA) EXTRACT, MARIS AQUA (DEAD SEA WATER).

Other information

STORAGE AND HANDLING SECTION

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

Questions or comments

OTC - QUESTIONS SECTION

Call toll free 1-800-366-7254

SPL UNCLASSIFIED SECTION

Manufactured by AHAVA Dead Sea
Laboratories, Dead Sea, Israel, 8698000

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DEAD SEA
NATURALS

BY AHVANA

FACE MOISTURIZER
BROAD SPECTRUM
SPF 20

Mineral-infused hydration
and protection for smooth
and even tone skin

VEGAN

FOR ALL SKIN TYPES

Principal Display Panel - 50 ml Tube Carton
Principal Display Panel - 50 ml Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60289-291-242023-11-13C16284748780-1f386c64a-0a2d-0266-e053-dadaa90a7c1aDead Sea Natural Face Moisturizer Broad Spectrum SPF 20
60289-291-242023-01-30C16284748780-1f386c64a-0a2d-0266-e053-dadaa90a7c1aDead Sea Natural Face Moisturizer Broad Spectrum SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60289-291-24Dead Sea Natural Face Moisturizer Broad Spectrum SPF 201 in 1 CARTONCREAM12
60289-291-24Dead Sea Natural Face Moisturizer Broad Spectrum SPF 2050 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60289-291DEAD SEA NATURAL FACE MOISTURIZER BROAD SPECTRUM SPF 20 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) CREAM [AHAVA DEAD SEA LABORATORIES LTD]2Current NDC, Legacy NDC, 2 package rows20231114_dee4bdb8-5c6f-42f6-b15c-d109cd2d3140.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60289-29160289-291-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
NIACINAMIDE25X51I8RD4IACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
HYDROGENATED OLIVE OIL CETYL ESTERSAUR5S128JMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BENZOTRIAZOLYL DODECYL P-CRESOL298PX4M11XIACT
SALICYLIC ACIDO414PZ4LPZIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
XANTHAN GUMTTV12P4NEEIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIISOBUTYL ADIPATE8OPY05ZY7SIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
SOYBEAN OIL241ATL177AIACT
.BETA.-SITOSTEROLS347WMO6M4IACT
ASCORBYL PALMITATEQN83US2B0NIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM HYDROXIDE55X04QC32IIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltddee4bdb8-5c6f-42f6-b15c-d109cd2d31402023-11-08WarningsExact identifier
ndc (package): 60289-291-24
ndc (product): 60289-291
ndc11 (package): 60289029124
spl id: 2aa67d0d-37f2-47af-82e7-8ed91f9d8501
spl set id: dee4bdb8-5c6f-42f6-b15c-d109cd2d3140

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.