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Sun Bum 30 Mineral Tinted Sunscreen Face

Sun Bum 30 Mineral Tinted Sunscreen Face

Approved
Approval ID

3a290aad-7f40-cb10-e063-6394a90a2e69

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 27, 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.

Titanium Dioxide, Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69039-734
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Titanium Dioxide, Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 27, 2025
FDA Product Classification

INGREDIENTS (21)

ORYZA SATIVA (RICE) BRANInactive
Code: R60QEP13IC
Classification: IACT
HELIANTHUS ANNUUS FLOWERING TOPInactive
Code: BKJ0J3D1BP
Classification: IACT
ZINC OXIDEActive
Quantity: 24 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
ROSEMARYInactive
Code: IJ67X351P9
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
FERROUS OXIDEInactive
Code: G7036X8B5H
Classification: IACT
ISOPROPYL TITANIUM TRIISOSTEARATEInactive
Code: 949E3KBJ1I
Classification: IACT
POLYAMIDE-5Inactive
Code: UEM62QMW5F
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
HYDROGEN DIMETHICONE (13 CST)Inactive
Code: 4QGR4P2YOI
Classification: IACT
DIMETHICONE CROSSPOLYMERInactive
Code: UF7620L1W6
Classification: IACT
OCTYLDODECYL OLEATEInactive
Code: MCA43PK7MH
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 58 mg in 1 mL
Code: 15FIX9V2JP
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
STEARALKONIUM HECTORITEInactive
Code: OLX698AH5P
Classification: IACT
PROPYLENE CARBONATEInactive
Code: 8D08K3S51E
Classification: IACT
CYCLOPENTASILOXANEInactive
Code: 0THT5PCI0R
Classification: IACT
SYNTHETIC WAX (540 MW)Inactive
Code: DW2TC44JRY
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

Titanium Dioxide 5.3%, Zinc Oxide 2.4%

OTC - PURPOSE SECTION

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

Purpose

Sunscreen

OTC - QUESTIONS SECTION

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

Questions?

1-877-978-6286

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 immediately.

Keep outer carton for complete labeling information.

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 40 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

cyclopentasiloxane, isopropyl myristate, polyamide-5, dimethicone crosspolymer, stearalkonium hectorite, polysilicone-11, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol, mica, iron oxides, propylene carbonate, synthetic wax, hydrogen dimethicone, isopropyl titanium triisostearate, aluminum hydroxide, silica silylate, octyldodecyl oleate

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Sun Bum 30 Mineral Tinted Sunscreen Face - FDA Drug Approval Details