Baby Bare Republic Mineral Sunscreen Softstick Spf 50

Baby Bare Republic Mineral Sunscreen Softstick Spf 50
SPL v2
SPL
SPL Set ID 1a603f62-86ec-4e66-a73f-718c5d012676
Route
TOPICAL
Published
Effective Date 2021-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (17.9 g)
Inactive Ingredients
Shea Butter Medium-chain Triglycerides Safflower Seed Oil Polyglyceryl-6 Esters Chamomile Dimethicone Ethyl Ferulate Cottonseed Oil Helianthus Annuus Seed Wax Hydrogenated Rapeseed Oil Isododecane Neopentyl Glycol Diheptanoate Polyhydroxystearic Acid (2300 Mw) Polymethylsilsesquioxane (4.5 Microns) Stearyl Alcohol Tocopherol Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-03
Description

Drug Facts Active Ingredients Zinc Oxide 17.9%

Medication Information

Warnings and Precautions

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.

Indications and Usage

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

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

●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 spection SPF of 15 or higher and other sun protection

measures including: SPF of 15 or higher and other sun protection

● limit time in the sun, especially from: 10 a.m. - 2 p.m.

● wear long-sleeve shirts, pants, hats, and sunglasses

●Children under 6 months: Ask a doctor

Description

Drug Facts Active Ingredients Zinc Oxide 17.9%

Section 42229-5

Questions or comments?

Call 760-940-2125

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if skin rash occurs

Section 51727-6

Inactive Ingredients Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethyl Ferulate, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Isododecane, Neopentyl Glycol Diheptanoate, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Stearyl Alcohol, Tocopherol, Triethoxycaprylylsilane

Section 55105-1

Purpose

Suncreen

Section 55106-9

Drug Facts

Active Ingredients

Zinc Oxide 17.9%

Section 60561-8

Other information

  • protect this product from excessive heat and direct sun
Coola Label

BABY BARE

REPUBLIC

MINERAL SUNSCREEN

Softstick

0.9 OZ / 25 g

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

San Diego, CA 92010. All Rights Reserved.

WWW.GOBAREOUTSIDE.COM



res

Structured Label Content

Indications and Usage (34067-9)

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 (34068-7)

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

●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 spection SPF of 15 or higher and other sun protection

measures including: SPF of 15 or higher and other sun protection

● limit time in the sun, especially from: 10 a.m. - 2 p.m.

● wear long-sleeve shirts, pants, hats, and sunglasses

●Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Questions or comments?

Call 760-940-2125

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if skin rash occurs

Section 51727-6 (51727-6)

Inactive Ingredients Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethyl Ferulate, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Isododecane, Neopentyl Glycol Diheptanoate, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Stearyl Alcohol, Tocopherol, Triethoxycaprylylsilane

Section 55105-1 (55105-1)

Purpose

Suncreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Zinc Oxide 17.9%

Section 60561-8 (60561-8)

Other information

  • protect this product from excessive heat and direct sun
Coola Label (COOLA Label)

BABY BARE

REPUBLIC

MINERAL SUNSCREEN

Softstick

0.9 OZ / 25 g

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

San Diego, CA 92010. All Rights Reserved.

WWW.GOBAREOUTSIDE.COM



res

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Source: dailymed · Ingested: 2026-02-15T12:02:32.684117 · Updated: 2026-03-14T23:02:09.430554