FDA.reportPublic FDA data

SUN Solar Defense Hydrating

Manufacturer
Allure Labs, Inc.
Effective date
2010-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:58

Label at a glance#

ProductSUN Solar Defense Hydrating
Active ingredientZINC OXIDE, OCTINOXATE, OXYBENZONE, OCTISALATE
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide 5%

Ethylhexyl Methoxycinnamate (Octinoxate) 7.5%

Benzophenone-3 3%

Ethylhexyl Salicylate (Octisalate) 5%

INDICATIONS & USAGE SECTION

Uses:

A hydrating UVA/UVB broad spectrum daily moisturizer. Provides ultimate protection against the aging effects of the sun and other environmental exposures. Enriched with essential vitamins and anti-oxidants that prevent free radical damage and preserving skin hydration for the entire day.

Water-resistant

Paraben-free

Directions:

Apply to cleaned skin every morning for ultimate protection.

Indications: Dry, dehydrated, rosacea, sensitive.

WARNINGS AND PRECAUTIONS SECTION

Warnings:

For External use only

When using this product-

Keep out of eyes. If contact occurs rinse with water.

Discontinue use if irritation or redness occurs

Keep out of reach of children

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Deionized water (Aqua), C12-15 Alkyl Benzoate, Glyceryl Stearate (and) PEG-100 Stearate, Glycerin, Sodium Hyaluronate, Imperata Cylindrica Root Extract, Octyl Dodecyl Neopentanoate, Sorbitol, Caprylic/Capric Truglyceride, Camellia sinensis (Green Tea) Leaf Extract, Biosaccharide Gum-1, Algae Extract and Mugwort Extract, Caprylyl Glycol and Phnoxyethanol and Hexylene Glycol, Sodium PCA, Lecithin, Sorbitan Stearate, Symphytum Officinale Extract and Plantago Ovata Seed Extract, Yeast Extract, Aloe Barbadensis Leaf Extract, Spiraea Ulmaria Flower Extract (and) Centella Asiatica Extract, Magnesium Aluminum Silicate, Tocopheryl Acetate, Ascorbyl Palmitate, Disodium EDTA, Dipotassium Glycyrrizate, Amino Acids.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the Product:

Image of the Product
Image of the Product

Distributor:

Image International

Palm Beach, FL 33411 USA

www.imageskincare.com

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62742-4037-12019-10-21C16284748780-1956f9ecf-d3b6-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4037-1SUN Solar Defense Hydrating118 mL in 1 TUBECREAM1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4037SUN SOLAR DEFENSE HYDRATING (ZINC OXIDE, ETHYLHEXYL METHOXYCINNAMATE, BENZOPHENONE, ETHYLHEXYL SALICYLATE) CREAM [ALLURE LABS, INC.]1Legacy NDC, 1 package rows20100701_ebfc03d8-d4dd-4d01-b0fe-f8f6c097c342.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-403762742-4037-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB

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
cea5b90c-cb67-4803-910e-625cba66ff37ebfc03d8-d4dd-4d01-b0fe-f8f6c097c3422010-06-30WarningsExact identifier
spl id: cea5b90c-cb67-4803-910e-625cba66ff37
spl set id: ebfc03d8-d4dd-4d01-b0fe-f8f6c097c342

Reported adverse events (FAERS/openFDA)#

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