FDA.reportPublic FDA data

Hydrating Antioxidant Moiturizer

Manufacturer
Walgreen Company
Effective date
2017-11-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:56

Label at a glance#

ProductHydrating Antioxidant Moiturizer
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure11 sections

Storage and handling

Other informatio n  •protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone, 2.1%

Homosalate, 4.0%

Octisalate, 4.0%

Octocrylene, 2.0%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Uses  •helps prevent sunburn  •If used as directed

with other protection measures (see

Directions), decreases the risk of skin cancer and

early skin aging caused by the sun.

WARNINGS SECTION

Warnings

For external use only.   

Do not use on  •damaged or broken skin

When using this product  •keep out of eyes. Rinse

with water to remove.

Stop use and ask a doctor  •if rash occurs.

WARNINGS AND PRECAUTIONS SECTION

WARNINGS: FOR EXTERNAL USE ONLY.

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE

THOROUGHLY WITH WATER. IF IRRITATION OR RASH OCCURS,

DISCONTINUE USE. KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, SEEK MEDICAL ATTENTION OR CONTACT  POISON

CONTROL CENTER RIGHT AWAY.

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS?

call 1-800-925-4733

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.

DOSAGE & ADMINISTRATION SECTION

Directions

•apply liberally 5 minutes before sun exposure

•reapply at least every 2 hours

•use water resistant sunscreen if swimming or

sweating.

•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 a Broad

Spectrum SPF value of 15 or higher and other sun

protection measures including:

   •limit time in the sun, specially from 10 a.m. - 2 p.m.

   •wear long-sleeved shirts, pants, hats and sunglasses.

STORAGE AND HANDLING SECTION

Other information  •protect the product in this

container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive ingredients  Water, Dimethicone,

Trisiloxanane, Isononyl Isononanoate, Glycerin, Cetyl Alcohol,

Steareth-21, Nylon-12, Silica, Stearyl Alcohol, Glyceryl Stearate,

PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin,

Dimethicone Crosspolymer, Fragrance, Propylene Glycol,

Myrtus Communis Extract, Xanthan Gum, Retinyl Palmitate, Polysorbate 20, Carbomer,

Disodium EDTA, Ascorbic Acid, Sodium Hydroxide, ,BHT, Hyaluronic Acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0540-012023-01-30C16284748780-1f386c649-adb7-0266-e053-dadaa90a7c1adbf44ea9-1073-4a8f-b44b-2bf1a1b48081

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0540-01Hydrating Antioxidant Moiturizer118 mL in 1 PACKAGECREAM1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0540HYDRATING ANTIOXIDANT MOITURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [WALGREEN COMPANY]1Legacy NDC, 1 package rows20171109_dbf44ea9-1073-4a8f-b44b-2bf1a1b48081.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-05400363-0540-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
TRISILOXANE9G1ZW13R0GIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
STEARETH-2153J3F32P58IACT
NYLON-12446U8J075BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MYRTUS COMMUNIS LEAFU20N87188FIACT
XANTHAN GUMTTV12P4NEEIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
POLYSORBATE 207T1F30V5YHIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
HYALURONIC ACIDS270N0TRQYIACT

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
8fb13b3f-184b-4491-adfa-a8d924801682dbf44ea9-1073-4a8f-b44b-2bf1a1b480812017-11-09WarningsExact identifier
spl id: 8fb13b3f-184b-4491-adfa-a8d924801682
spl set id: dbf44ea9-1073-4a8f-b44b-2bf1a1b48081

Reported adverse events (FAERS/openFDA)#

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