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Baby Bum Mineral 50 Mineral Sunscreen Face Stick

Baby Bum Mineral 50 Mineral Sunscreen Face Stick

Approved
Approval ID

3d3a0d5c-a366-22fc-e063-6394a90a308b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 25, 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 Code69039-828
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 25, 2025
FDA Product Classification

INGREDIENTS (17)

CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OILInactive
Code: 65UEH262IS
Classification: IACT
COCOS NUCIFERA (COCONUT) OILInactive
Code: Q9L0O73W7L
Classification: IACT
ORYZANOLInactive
Code: SST9XCL51M
Classification: IACT
THEOBROMA CACAO (COCOA) SEED BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
COPERNICIA CERIFERA (CARNAUBA) WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ZINC OXIDEActive
Quantity: 192 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
LINUM USITATISSIMUM (LINSEED) SEED OILInactive
Code: 84XB4DV00W
Classification: IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
EUPHORBIA CERIFERA (CANDELILLA) WAXInactive
Code: WL0328HX19
Classification: IACT
HYDROLYZED JOJOBA ESTERSInactive
Code: UDR641JW8W
Classification: IACT
LIMNANTHES ALBA (MEADOWFOAM) SEED OILInactive
Code: 412ZHA4T4Y
Classification: IACT
RICE BRANInactive
Code: R60QEP13IC
Classification: IACT
PERSEA GRATISSIMA (AVOCADO) OILInactive
Code: 6VNO72PFC1
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 19.2%

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

Cocos Nucifera (Coconut) Oil
Persea Gratissima (Avocado) Oil
Limnanthes Alba (Meadowfoam) Seed Oil
Linum Usitatissimum (Linseed) Seed Oil
Oryza Sativa (Rice Bran) Wax
Butyloctyl Salicylate
Ozokerite
Copernicia Cerifera (Carnauba) Wax
Butyrospermum Parkii (Shea Butter)
Oryzanol
Euphorbia Cerifera (Candelilla) Wax
Theobroma Cacao (Cocoa) Seed Butter
Carthamus Tinctorius (Safflower) Seed Oil
Jojoba Esters
Tocopherol
Bisabolol

OTC - QUESTIONS SECTION

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

Questions?

1-877-978-6286

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