Coola Mineral Baby SPF 50 Unscented Sunscreen Lotion

Manufacturer
Bell International Laboratories, Inc
Effective date
2017-10-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:11:14

Label at a glance#

ProductMineral Baby Unscented SPF 50 Broad Spectrum
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

helps prevent sunburn if used as idrected 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 with a broad spectrum SPF of 15 or higher and other sun protection measures including: llimit time in the sun,...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7.3%

Zinc Oxide 4.3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn

if used as idrected 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 with a broad spectrum SPF of 15 or higher and other sun protection measures including:

  • llimit 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

Aloe Barbadensis Leaf Extract (ORGANIC), Beeswax (ORGANIC), Bisabolol, Butyrospermum Parkii (ORGANIC Shea Butter), Carthamus Tinctorius (Safflower) Oleosomes, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Jojoba Esters, Oryzanol, Persea Gratissima (ORGANIC Avocado) Oil, Sesamum Indicum (ORGANIC Sesame) Seed Oil, Silica, Theobroma Cacao (ORGANIC Cocoa) Seed Butter, Tocopherol, Water

Other information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

natural product dispenses best above 67 F/19 C

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76150-12276150-122-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
5bec6746-8978-1c22-e053-2a91aa0a797b5bec6746-8977-1c22-e053-2a91aa0a797b2017-10-19WarningsExact identifier
spl id: 5bec6746-8978-1c22-e053-2a91aa0a797b
spl set id: 5bec6746-8977-1c22-e053-2a91aa0a797b

Reported adverse events (FAERS/openFDA)#

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