Baby Bare Republic Mineral Sunscreen

Manufacturer
Coola, LLC | Gordon Laboratories, Inc
Effective date
2020-10-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:09:39

Label at a glance#

ProductBaby Bare Republic Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection methods (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally for 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: limit time in the s...

Storage and handling

may stain fabrics protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Purpose

OTC - PURPOSE SECTION

Zinc Oxide 25%.........Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection methods (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For External Use Only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a 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 for 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:

  • limit time in the sun, especially from 10a.m. - 2p.m.
  • wear long sleeve shirts, pants, hats and sunglasses
  • children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Extract, Buyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorious (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Euphorbia Cerifera (Candelilla) Was, Helianthus Annuus (Sunflower) Seed Oil, Olea Europea (Olive) Fruit Oil, Ozokerite, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Therobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethoxycaprylylsilane

Other Information

STORAGE AND HANDLING SECTION

  • may stain fabrics
  • protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call 760-940-2125

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-00379753-003-01

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f0ff6c1c-a2be-11d1-e053-2a95a90adb24b2bc6741-dd71-1e7c-e053-2995a90adb7b2022-12-29WarningsExact identifier
spl set id: b2bc6741-dd71-1e7c-e053-2995a90adb7b

Reported adverse events (FAERS/openFDA)#

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