MedPath

Sun Bum 50 Mineral Sunscreen Face Stick

Sun Bum 50 Mineral Sunscreen Face Stick

Approved
Approval ID

3d48d467-4b6b-c477-e063-6294a90a5a0d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 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 Code69039-829
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (16)

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
ETHYL FERULATEInactive
Code: 5B8915UELW
Classification: IACT
ZINC OXIDEActive
Quantity: 138 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
EUPHORBIA CERIFERA (CANDELILLA) WAXInactive
Code: WL0328HX19
Classification: IACT
PONGAMIA PINNATA SEEDInactive
Code: C2BRV53B1V
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
COPERNICIA CERIFERA (CARNAUBA) WAXInactive
Code: R12CBM0EIZ
Classification: IACT
METHYL DIHYDROABIETATEInactive
Code: 7666FJ0J9F
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
TAPIOCA STARCHInactive
Code: 24SC3U704I
Classification: IACT
THEOBROMA CACAO (COCOA) SEED BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)Inactive
Code: T9296U138P
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 13.8%

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

caprylic/capric triglyceride, ozokerite, butyloctyl salicylate, dimethicone/vinyl dimethicone crosspolymer, tapioca starch, butyrospermum parkii (shea) butter, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, theobroma cacao (cocoa) seed butter, methyl dihydroabietate, ethyl ferulate, polyester-8, pongamia pinnata seed extract, tocopheryl acetate, triethoxycaprylylsilane

OTC - QUESTIONS SECTION

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

Questions?

1-877-978-6286

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