FDA.reportPublic FDA data

Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 New

Manufacturer
Sun Bum, LLC
Effective date
2025-08-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:05

Label at a glance#

ProductSun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 New
Active ingredientZINC OXIDE
Label structure11 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 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 v...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 21%

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 on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of Children

Directions

INSTRUCTIONS FOR USE 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 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 and sunglasses

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well before use

• apply liberally 15 minutes before sun exposure

Other Information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, ETHYLHEXYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER, CETEARYL ALCOHOL, MICROCRYSTALLINE CELLULOSE, COCO-GLUCOSIDE, ETHYLHEXYLGLYCERIN, ISOSTEARIC ACID, LECITHIN, PHENOXYETHANOL, POLYGLYCERYL-3 PENTARICINOLEATE, POLYHYDROXYSTEARIC ACID, PONGAMIA PINNATA SEED

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Primary Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary ArtworkPrimary Artwork

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-770-01Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 New88 mL in 1 BOTTLE, PLASTICLOTION882
69039-770-02Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 New1 in 1 CARTONLOTION12

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-77069039-770-01, 69039-770-02

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
WATER059QF0KO0RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
COCO-GLUCOSIDEICS790225BIACT
CETEARYL ALCOHOL2DMT128M1SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ZINC OXIDESOI2LOH54ZACTIB
ETHYLHEXYL PALMITATE2865993309IACT

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
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 NewZINC OXIDESun Bum, LLC3b8e1d73-b023-cfbd-e063-6294a90ae29d2025-08-19WarningsExact identifier
ndc (package): 69039-770-01
ndc (package): 69039-770-02
ndc (product): 69039-770
ndc11 (package): 69039077001
ndc11 (package): 69039077002
spl id: 3cbbee59-b1dd-be99-e063-6294a90a9719
spl set id: 3b8e1d73-b023-cfbd-e063-6294a90ae29d

Reported adverse events (FAERS/openFDA)#

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