FDA.reportPublic FDA data

AHAVA

Manufacturer
AHAVA - Dead Sea Laboratories Ltd
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:42:27

Label at a glance#

ProductAHAVA Brightening Broad Spectrum SPF 20
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

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 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...

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 2.74%sunscreens

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For External Use Only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

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, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Stearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Sodium Citrate, Potassium Cetyl Phosphate, Hydrogenated Olive Oil Cetyl Esters, Phenoxyethanol, Hydrogenated Palm Glycerides, Aminomethyl Propanol, Cetearyl Alcohol, Benzotriazolyl Dodecyl p-Cresol, Parfum (Fragrance), Xanthan Gum, Ethylhexylglycerin, Butylene Glycol, Diisobutyl Adipate, Citric Acid, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Glycine Soja (Soybean) Oil, Ascorbic Acid, Ascorbyl Palmitate, Pseudoalteromonas Ferment Extract, Propylene Glycol, Lecithin, Hydrogenated Vegetable Glycerides Citrate, Sodium Benzoate, Potassium Sorbate, Beta-Sitosterol, Squalene (Phytosqualene), Helianthus Annuus (Sunflower) Sprout Extract, Lactic Acid, Commiphora Abyssinica Resin Extract, Sodium Hydroxide, Porphyra Umbilicalis Extract, Tocopherol (Vitamin E), Opuntia Ficus-Indica Fruit Extract, Zizyphus Jujuba Fruit Extract, Camellia Sinensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Calendula Officinalis Flower Extract, Rumex Occidentalis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Salicylic Acid, Tocopheryl (Vitamin E) Acetate, Phoenix Dactylifera (Date) Fruit Extract, Dunaliella Salina (Dead Sea Alga) Extract, Maris Aqua (Dead Sea Water/Osmoter).

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AHAVA

Brightening Cream
Broad Spectrum SPF 20

EVEN TONE

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60289-303-24AHAVA Brightening Broad Spectrum SPF 201 in 1 CARTONCREAM11
60289-303-24AHAVA Brightening Broad Spectrum SPF 2050 mL in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60289-303AHAVA BRIGHTENING BROAD SPECTRUM SPF 20 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) CREAM [AHAVA - DEAD SEA LABORATORIES LTD]1Current NDC, 2 package rows20241213_724bbb91-e273-4926-9ad6-a1657ffe4cd8.zip

Products#

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

DailyMed product names page 1 of 2 · 56 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60289-30360289-303-24

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 54 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Water059QF0KO0RIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Dimethicone92RU3N3Y1OIACT
GlycerinPDC6A3C0OXIACT
Octyldodecyl NeopentanoateX8725R883TIACT
Niacinamide25X51I8RD4IACT
Ascorbyl Glucoside2V52R0NHXWIACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Aloe Vera LeafZY81Z83H0XIACT
Stearyl Alcohol2KR89I4H1YIACT
Glyceryl Monostearate230OU9XXE4IACT
PEG-100 MonostearateYD01N1999RIACT
Sodium Citrate, Unspecified Form1Q73Q2JULRIACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Hydrogenated Olive Oil Cetyl EstersAUR5S128JMIACT
PhenoxyethanolHIE492ZZ3TIACT
Hydrogenated Palm GlyceridesYCZ8EM144QIACT
AminomethylpropanolLU49E6626QIACT
Cetostearyl Alcohol2DMT128M1SIACT
Benzotriazolyl Dodecyl p-Cresol298PX4M11XIACT
Xanthan GumTTV12P4NEEIACT
Ethylhexylglycerin147D247K3PIACT
Butylene Glycol3XUS85K0RAIACT
Diisobutyl Adipate8OPY05ZY7SIACT
Citric Acid Monohydrate2968PHW8QPIACT
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)255PIF62MSIACT
Soybean Oil241ATL177AIACT
Ascorbic AcidPQ6CK8PD0RIACT
Ascorbyl PalmitateQN83US2B0NIACT
Propylene Glycol6DC9Q167V3IACT
Sodium BenzoateOJ245FE5EUIACT
Potassium Sorbate1VPU26JZZ4IACT
.Beta.-SitosterolS347WMO6M4IACT
Squalene7QWM220FJHIACT
Helianthus Annuus Sprout4P26HG1S5WIACT
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
AHAVA Brightening Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd724bbb91-e273-4926-9ad6-a1657ffe4cd82024-12-10WarningsExact identifier
ndc (package): 60289-303-24
ndc (product): 60289-303
ndc11 (package): 60289030324
spl id: f3758d02-cb56-4323-87b3-a3e804ea7505
spl set id: 724bbb91-e273-4926-9ad6-a1657ffe4cd8

Reported adverse events (FAERS/openFDA)#

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