FDA.reportPublic FDA data

Sun Bum Mineral Sunscreen Spray Broad Spectrum SPF 50

Manufacturer
Sun Bum LLC
Effective date
2022-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:04

Label at a glance#

ProductSun Bum Mineral Sunscreen Broad Spectrum SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 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 to6 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 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 3.4%

Zinc oxide 16%

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

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • 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 room temperature above 120°F.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If  swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • hold container 4 to6 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 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 Protections Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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, and sunglasses

Other information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, butyloctyl salicylat, helianthus annus (sunflower) seed oil, dicaprylyl carbonate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, polyester-8, sodium stearoyl glutamate, coco-glucoside, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, tocopherol, glycerin, cellulose gum,bentonite, microcrystalline cellulose, caprylyl glycol, silica, polyhydroxystearic acid, citric acid, alumina, bisabolol, sodium gluconate, caprylhydroxamic acid

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-624-012025-01-30C16284748780-12cef2736-9beb-d83d-e063-dadaa90ab31fSun Bum Mineral Sunscreen Spray Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-624-01Sun Bum Mineral Sunscreen Broad Spectrum SPF 50170 g in 1 BOTTLELIQUID1702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-624SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LIQUID [SUN BUM LLC]2Legacy NDC, 1 package rows20220205_bcd11616-9f2d-97d8-e053-2a95a90a8ba5.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-62469039-624-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SUNFLOWER OIL3W1JG795YIIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PROPANEDIOL5965N8W85TIACT
ISOCETYL STEAROYL STEARATEIJV4LS383RIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
COCO GLUCOSIDEICS790225BIACT
ALOE VERA LEAFZY81Z83H0XIACT
BANANA4AJZ4765R9IACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
BENTONITEA3N5ZCN45CIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALUMINUM OXIDELMI26O6933IACT
LEVOMENOL24WE03BX2TIACT
SODIUM GLUCONATER6Q3791S76IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
d73e9fdb-db80-9410-e053-2a95a90a6e09bcd11616-9f2d-97d8-e053-2a95a90a8ba52022-02-04WarningsExact identifier
spl id: d73e9fdb-db80-9410-e053-2a95a90a6e09
spl set id: bcd11616-9f2d-97d8-e053-2a95a90a8ba5

Reported adverse events (FAERS/openFDA)#

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