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Sun Bum 50 Mineral Sunscreen 1 OZ

Sun Bum 50 Mineral Sunscreen 1 OZ

Approved
Approval ID

3c483d04-8942-5269-e063-6294a90a3881

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Sun Bum, LLC

DUNS: 028642574

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69039-797
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (26)

BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
SODIUM GLUCONATEInactive
Code: R6Q3791S76
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
SODIUM STEAROYL GLUTAMATEInactive
Code: 65A9F4P024
Classification: IACT
ARACHIDYL ALCOHOLInactive
Code: 1QR1QRA9BU
Classification: IACT
COCO-GLUCOSIDEInactive
Code: ICS790225B
Classification: IACT
THEOBROMA CACAO (COCOA) SEED BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
BEHENYL ALCOHOLInactive
Code: 9G1OE216XY
Classification: IACT
CELLULOSE GUMInactive
Code: K679OBS311
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)Inactive
Code: N7YC58165T
Classification: IACT
DIHEPTYL SUCCINATEInactive
Code: 057N7SS26Y
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ZINC OXIDEActive
Quantity: 200 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
COCOS NUCIFERA (COCONUT) OILInactive
Code: Q9L0O73W7L
Classification: IACT
METHYL DIHYDROABIETATEInactive
Code: 7666FJ0J9F
Classification: IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
ARACHIDYL GLUCOSIDEInactive
Code: 6JVW35JOOJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2025

Primary Artwork

Primary Artwork

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2025

Active Ingredients

Zinc Oxide 20%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2025

Warnings

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2025

Warnings

Keep Out Of Reach Of Children

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 1/1/2025

Directions

• 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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2025

Directions

• apply liberally 15 minutes before sun exposure

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 1/1/2025

Other Information

protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2025

Inactive Ingredients

METHYL DIHYDROABIETATE, TOCOPHEROL, POLYHYDROXYSTEARIC ACID, CITRIC ACID, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCO-GLUCOSIDE, BUTYLOCTYL SALICYLATE, COCOS NUCIFERA (COCONUT) OIL, THEOBROMA CACAO (COCOA) SEED BUTTER, ETHYLHEXYLGLYCERIN, WATER, DIHEPTYL SUCCINATE, CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER, SODIUM STEAROYL GLUTAMATE, CETEARYL ALCOHOL, ARACHIDYL ALCOHOL, CETYL ALCOHOL, BEHENYL ALCOHOL, BISABOLOL, ARACHIDYL GLUCOSIDE, MICROCRYSTALLINE CELLULOSE, CELLULOSE GUM, SODIUM HYALURONATE, SODIUM GLUCONATE, PHENOXYETHANOL

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/1/2025

Questions?

1-877-978-6286

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Sun Bum 50 Mineral Sunscreen 1 OZ - FDA Drug Approval Details