FDA.reportPublic FDA data

5407 Sunscreen

Manufacturer
Innovation Specialties
Effective date
2026-10-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-11-10 04:04:25

Label at a glance#

Product5407 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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

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, Isopropyl Myristate, Cetearyl Alcohol, Glyceryl Stearate, Ceteth-25, Phenoxyethanol, Fragrance, Methylparaben, Popylparaben, Disodium EDTA, BHT

Other information

STORAGE AND HANDLING SECTION

•Protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

HOTLINE # 1-855-755-5346

SPL UNCLASSIFIED SECTION

1FL OZ (30ML)

Product # 5407

Manufactured for Innovation Line
Culver City, CA 90230

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Broad Spectrum SPF30

Sunscreen Lotion

(NetW 1FL OZ/30ML)

labellabel

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76138-22376138-223-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CETEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE230OU9XXE4IACT
CETETH-255KLY4IOG20IACT
BEESWAX2ZA36H0S2VIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE DISODIUM7FLD91C86KIACT
BHT1P9D0Z171KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-07-10full-release2026-06-01 00:15:10

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
5407 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialtiesf3f86164-2a2e-4f1f-a562-c1ff6cf503222024-07-10WarningsExact identifier
ndc (package): 76138-223-01
ndc (product): 76138-223
ndc11 (package): 76138022301
spl set id: f3f86164-2a2e-4f1f-a562-c1ff6cf50322

Reported adverse events (FAERS/openFDA)#

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