FDA.reportPublic FDA data

Sunscreen SPF30

Manufacturer
Broder Bros Prime Line
Effective date
2025-11-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:18:13

Label at a glance#

ProductSunscreen SPF30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 sections

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

avobenzone (3%)

homosalate (10%)

octisalate (5%)

octocrylene (10%)

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Use • Helps prevent sunburn

WARNINGS SECTION

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

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

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 for 15 minutes before sun exposure and as needed.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Acrylate/Beheneth-25 Methacrylate Copolymer, Bisabolol, Caprylyl Glycol, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Phenoxyethanol, Potassium Cetyl Phosphate, Triethanolamine, VP/Hexadecene Copolymer, Water

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

OTC - QUESTIONS SECTION

Questions?1-800-873-7746 M-F 8am-5pm EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunscreen

SPF30

Net 1 FL OZ (29.6ML)

Dist. by Broder Bros., Co. dba Primeline Gaffney, SC 29341

Made in China

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71513-708-01Sunscreen SPF3029.6 mL in 1 BOTTLELOTION29.63

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71513-70871513-708-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
LEVOMENOL24WE03BX2TIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
TROLAMINE9O3K93S3TKIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
Sunscreen SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBroder Bros Prime Line0a360f87-76cf-e6a7-e063-6294a90a07fb2025-11-17WarningsExact identifier
ndc (package): 71513-708-01
ndc (product): 71513-708
ndc11 (package): 71513070801
spl id: 43d0ff9a-d19e-ab24-e063-6394a90a107c
spl set id: 0a360f87-76cf-e6a7-e063-6294a90a07fb

Reported adverse events (FAERS/openFDA)#

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