FDA.reportPublic FDA data

Equate

Manufacturer
Wal-Mart Stores, Inc.
Effective date
2018-05-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:30

Label at a glance#

ProductEquate
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Storage and handling

Other information •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%

Octisalate, 5%

Octocrylene, 5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

Sunscreen

Sunscreen

INDICATIONS & USAGE SECTION

Uses

•helps prevent sunburn

•if used as directed with other sun 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

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 15 minutes before sun

exposure •reapply at least every 2 hours •use water

resistant sunscrenn 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 SpectrumSPF

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.

STORAGE AND HANDLING SECTION

Other information •protect the product in this

container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Cyclopentasiloxane, Glycerin, Glyceryl Stearate,

PEG-100 Stearate, Caprylic/Capric Triglyceride, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil,

Myristyl Myristate, Cetearyl Alcohol, Stearic Acid, Squalane, Polyglyceryl-10 Pentastearate,

Behenyl Alcohol, Sodium Steroyl Lactylate, Phenoxyethanol, Ethylhexylglycerin,

Diethylhexyl 2,6-Naphthalate, Polyacrylate-13, Polyisobutene, Polysorbate 20,

Butylene Glycol, Carbomer, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7,

Steareth-2, Tocopheryl Acetate (Vitamin E), Triethanolamine, Fragrance,

Lecithin, Soy Isoflavones, Polysorbate 80, Xanthan Gum, Titanium Dioxide,

Trimethoxycaprylylsilane, Allantoin, Disodium EDTA, Dipalmitoyl Hydroxyproline,

Glycine Soja (Soybean) Protein, Retinyl Palmitate (Vitamin A).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-818-182020-01-31C16284748780-19d75b9d0-7d05-f424-e053-dadaa90a57ceee2b75ba-3c2e-414b-b5d6-dede5668851e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-818-18Equate1 in 1 CARTONCREAM12
49035-818-18Equate48 g in 1 JARCREAM482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-818EQUATE (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [WAL-MART STORES, INC.]2Legacy NDC, 2 package rows20180511_ee2b75ba-3c2e-414b-b5d6-dede5668851e.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-81849035-818-18

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
YELLOW WAX2ZA36H0S2VIACT
JOJOBA OIL724GKU717MIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARIC ACID4ELV7Z65APIACT
SQUALANEGW89575KF9IACT
POLYGLYCERYL-10 PENTASTEARATEPMX5872701IACT
DOCOSANOL9G1OE216XYIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
SODIUM ACRYLATE7C98FKB43HIACT
POLYISOBUTYLENE (1300 MW)241BN7J12YIACT
POLYSORBATE 207T1F30V5YHIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CARBOMER 9404Q93RCW27EIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
STEARETH-2V56DFE46J5IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SOY ISOFLAVONES71B37NR06DIACT
POLYSORBATE 806OZP39ZG8HIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIMETHOXYCAPRYLYLSILANEFZ07E4LW2MIACT
ALLANTOIN344S277G0ZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIPALMITOYL HYDROXYPROLINEE6AHA53N1HIACT

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
2e6b8cc7-c42e-48d0-b473-e1f4ed59e390ee2b75ba-3c2e-414b-b5d6-dede5668851e2018-05-10WarningsExact identifier
spl id: 2e6b8cc7-c42e-48d0-b473-e1f4ed59e390
spl set id: ee2b75ba-3c2e-414b-b5d6-dede5668851e

Reported adverse events (FAERS/openFDA)#

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