FDA.reportPublic FDA data

Sun Bum Broad Spectrum SPF 30 Suncreen Spray

Manufacturer
Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date
2022-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:55:25

Label at a glance#

ProductSun Bum Broad Spectrum SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 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

shake well before use hold container 4 to 6 inches from the skin to apply spray liberally and spread evenly by hand 15 minutes before sun exposure. do not spray directly into face. Spray on hands then apply to face. do not apply in windy conditions. use in a well-ventilated area. reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 3.75%

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

SPL UNCLASSIFIED SECTION

Flammable: do not use near heat, flame, or while smoking

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.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

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 product is swalowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • hold container 4 to 6 inches from the skin to apply
  • spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions. use in a well-ventilated area.
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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 Spectrum SPF 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 & sunglasses

Other information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol denat. (67%), acrylates/octylacrylamide copolymer, C12-15 alkyl benzoate, dicaprylyl carbonate, PPG-5-ceteth-20, fragrance, tocopherol

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Sun Bum Broad Spectrum SPF 30 Sunscreen Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-024713630-0247-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
ALCOHOL3K9958V90MIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
DICAPRYLYL CARBONATE609A3V1SUAIACT
PPG-5-CETETH-204AAN25P8P4IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT

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
e672cd1c-0717-3ee8-e053-2a95a90a9e55e672c8aa-fad3-4a4c-e053-2a95a90a0e2e2022-08-17WarningsExact identifier
spl id: e672cd1c-0717-3ee8-e053-2a95a90a9e55
spl set id: e672c8aa-fad3-4a4c-e053-2a95a90a0e2e

Reported adverse events (FAERS/openFDA)#

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