FDA.reportPublic FDA data

5281 SUNSCREEN

Manufacturer
Innovation Specialties
Effective date
2024-07-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:15:09

Label at a glance#

Product5281 SUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure10 sections

Indications and 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.

Dosage and administration

•Apply liberally 15 minutes exposure. •reapply: •after 40 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours. Sun Protection Measure. 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 of 15 higher and other sun protection measures including: •limit time in the sun, especia...

Storage and handling

•Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

•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

WARNINGS SECTION

For external use only

Do not useon damaged or broken skin.

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

Stop use and ask a doctorif rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children.If product swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

•Apply liberally 15 minutes exposure. •reapply: •after 40 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours.

Sun Protection Measure.
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 of 15 higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m-2 p.m. •wear long-sleeve shirts, pants, hats and sunglasses •children under 6 months: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Other Information

STORAGE AND HANDLING SECTION

•Protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call:1-855-755-5346

SPL UNCLASSIFIED SECTION

Broad Spectrum SPF30

Product # 5281
Made in China for Innovation Line
Culver City, CA 90230

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Innovation-219Innovation-219

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-219-052024-01-30C16284748780-11030e365-4bd2-111a-e063-dadaa90a10e25281 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-219-055281 SUNSCREEN15 mL in 1 BOTTLELOTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-2195281 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES]3Current NDC, Legacy NDC, 1 package rows20240712_86fc4539-e1c5-4d0f-a418-f48729cb2b20.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76138-21976138-219-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
LEVOMENOL24WE03BX2TIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
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
5281 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties86fc4539-e1c5-4d0f-a418-f48729cb2b202024-07-10WarningsExact identifier
ndc (package): 76138-219-05
ndc (product): 76138-219
ndc11 (package): 76138021905
spl id: 1cee97c2-00a1-c8b8-e063-6294a90ac4c6
spl set id: 86fc4539-e1c5-4d0f-a418-f48729cb2b20

Reported adverse events (FAERS/openFDA)#

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