FDA.reportPublic FDA data

Mineral Baby

Manufacturer
Bell International Laboratories, Inc.
Effective date
2017-11-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:10:37

Label at a glance#

ProductMineral Baby SPF 50 Broad Spectrum
Active ingredientZINC OXIDE
Label structure7 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

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 wtih a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.0%

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 doctor if skin rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure

reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

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 wtih a broad spectrum SPF of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am-2pm
  • wear long-sleeve shirts, pants, hats and sunglasses

children under 6 monts: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Beeswax (ORGANIC), Bisabolol, Butyrospermum Parkii (ORGANIC Shea Butter), Calophyllum Tacamahaca (ORGANIC Tamanu) Seed Oil, Chamomilla Recutita (ORGANIC Matricaria) Flower Extract, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Helianthus Annuus (ORGANIC Sunflower) Seed Oil., Helianthus Annuus (ORGANIC Sunflower) Seed Wax, Jojoba Esters, Linum Usitatissimum (ORGANIC Linseed) Seed Oil, Ozokerite, Persea Gratissima (ORGANIC Avocado) Oil, Prunus Amygdalus Dulcis (ORGANIC Sweet Almond) Oil, Ricinus Communis (ORGANIC Castor) Seed Oil, Rubus Idaeus (ORGANIC Raspberry) Seed Oil, Sesamum Indicum (ORGANIC Sesame) Seed Oil, Simmondsia Chinensis (ORGANIC Jojoba) Seed Oil, Theobroma Cacao (ORGANIC Cocoa) Seed Butter, Tocopherol, Urtica Dioica (ORGANIC Nettle) Extract

Other information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

may stain fabrics

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76150-21076150-210-39

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERESINQ1LS2UJO3AIACT
CARNAUBA WAXR12CBM0EIZIACT
SHEA BUTTERK49155WL9YIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
ZINC OXIDESOI2LOH54ZACTIB
JOJOBA OIL724GKU717MIACT
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
COCOA BUTTER512OYT1CRRIACT
TOCOPHEROLR0ZB2556P8IACT
CHAMOMILEFGL3685T2XIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
CALOPHYLLUM TACAMAHACA SEED OIL05G85L61OEIACT
LINSEED OIL84XB4DV00WIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
LEVOMENOL24WE03BX2TIACT
COCONUT OILQ9L0O73W7LIACT
AVOCADO OIL6VNO72PFC1IACT
SESAME OILQX10HYY4QVIACT
RASPBERRY SEED OIL9S8867952AIACT
ALMOND OIL66YXD4DKO9IACT
CASTOR OILD5340Y2I9GIACT

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
b8dfa46c-ee66-effc-e053-2995a90a546e5d069775-9805-06e3-e053-2991aa0a7ee42021-01-14WarningsExact identifier
spl set id: 5d069775-9805-06e3-e053-2991aa0a7ee4

Reported adverse events (FAERS/openFDA)#

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