FDA.reportPublic FDA data

Sun Bum Mineral Sunscreen Lotion Broad Spectrum SPF 50

Manufacturer
Sun Bum LLC
Effective date
2022-02-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:04

Label at a glance#

ProductSun Bum Mineral Sunscreen Broad Spectrum SPF 50
Active ingredientZINC OXIDE
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 apply liberally 15 minutes before sun exposure. 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 1...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 20%

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.

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
  • apply liberally 15 minutes before sun exposure.
  • 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, cocos nucifera (coconut) oil, butyloctyl salicylate, diheptyl succinate, methyl dihydroabietate, butyrospermum parkii (shea butter), capryloyl glycerin/sebacic acid copolymer, sodium stearoyl glutamate, cetearyl alcohol, arachidyl alcohol, coco glucoside, tocopherol, theobroma cacao (cocoa) seed butter, cetyl alcohol, behenyl alcohol, bisabolol, arachidyl glucoside, microcrystalline cellulose, cellulose gum, sodium hyaluronate, sodium gluconate, phenoxyethanol, citric acid, ethylhexylglycerin, polyhydroxystearic acid

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Package Labeling:69039-623-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
69039-623-012025-01-30C16284748780-12cef2736-88a0-d83d-e063-dadaa90ab31fSun Bum Mineral Sunscreen Lotion Broad Spectrum SPF 50
69039-623-022025-01-30C16284748780-12cef2736-88a0-d83d-e063-dadaa90ab31fSun Bum Mineral Sunscreen Lotion Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-623-01Sun Bum Mineral Sunscreen Broad Spectrum SPF 5088 mL in 1 TUBELOTION883
69039-623-02Sun Bum Mineral Sunscreen Broad Spectrum SPF 5030 mL in 1 TUBELOTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-623SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE) LOTION [SUN BUM LLC]3Legacy NDC, 2 package rows20220205_bcd0d483-f506-4c7c-e053-2995a90a5733.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-62369039-623-01, 69039-623-02

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
COCONUT OILQ9L0O73W7LIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIHEPTYL SUCCINATE057N7SS26YIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
SHEA BUTTERK49155WL9YIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
COCO GLUCOSIDEICS790225BIACT
TOCOPHEROLR0ZB2556P8IACT
COCOA BUTTER512OYT1CRRIACT
CETYL ALCOHOL936JST6JCNIACT
DOCOSANOL9G1OE216XYIACT
LEVOMENOL24WE03BX2TIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM GLUCONATER6Q3791S76IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
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
d72eed5b-3a59-08db-e053-2995a90a9668bcd0d483-f506-4c7c-e053-2995a90a57332022-02-04WarningsExact identifier
spl id: d72eed5b-3a59-08db-e053-2995a90a9668
spl set id: bcd0d483-f506-4c7c-e053-2995a90a5733

Reported adverse events (FAERS/openFDA)#

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