FDA.reportPublic FDA data

5281 sunscreen

Manufacturer
Innovation Specialties
Effective date
2017-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:12:48

Label at a glance#

Product5281 sunscreen
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
Label structure11 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 before sun 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 ...

Storage and handling

•protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%
Octisalate 2%
Oxybenzone 4%
Titanium Dioxide 2.5%

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 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 product swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

•apply liberally 15 minutes before sun 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, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Glycerin, Glyceryl Stearate, Myristyl Propionate, Propylene Glycol Dioleate, Ceteareth-25, PEG-9 Dimethicone, Xanthan Gum, Disodium EDTA, Fragrance.

Other information

STORAGE AND HANDLING SECTION

•protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

DIN 02448890

Made in China for Innovation line.

Los Angeles CA 90066

Questions or Comments?

Call:1-855-755-5346

SPL UNCLASSIFIED SECTION

Broad Spectrum SPF30 Lotion

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-207-052022-05-20C16284748780-19d75b9d0-8d37-f424-e053-dadaa90a57ce5281 sunscreen
76138-207-052020-01-31C16284748780-19d75b9d0-8d37-f424-e053-dadaa90a57ce5281 sunscreen

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76138-20776138-207-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MYRISTYL PROPIONATEP59053E7NJIACT
PROPYLENE GLYCOL DIOLEATE84T0LSN7U6IACT
CETEARETH-258FA93U5T67IACT
PEG-9 DIMETHICONE (400 CST)9OZ27X065DIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

Source Document#

Source XML · Source PDF

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
ff2ed981-2e87-444f-8e91-30e440528b8f1fa61521-168f-4eab-84a0-3a6aba4fce132022-05-13WarningsExact identifier
spl set id: 1fa61521-168f-4eab-84a0-3a6aba4fce13

Reported adverse events (FAERS/openFDA)#

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