Bare Republic Sheer Zinc Oxide Sunscreen Lotion

Bare Republic Sheer Zinc Oxide Sunscreen Lotion
SPL v3
SPL
SPL Set ID 6a0db9da-ee45-4ab7-80de-4bf189efe75f
Route
TOPICAL
Published
Effective Date 2022-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (17.9 g)
Inactive Ingredients
Neopentyl Glycol Diheptanoate Isododecane Medium-chain Triglycerides Hydrogenated Rapeseed Oil Polymethylsilsesquioxane (11 Microns) Stearyl Alcohol Helianthus Annuus Seed Wax Dimethicone Ethyl Ferulate Triethoxycaprylylsilane Polyhydroxystearic Acid (2300 Mw) Tocopherol Shea Butter Levant Cottonseed Oil Safflower Oil Chamomile .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-16

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 spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

●Children under 6 months: Ask a doctor

Description

Drug Facts Active Ingredients Zinc Oxide 17.9%

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

Neopentyl Glycol Diheptanoate, Isododecane, Caprylic/Capric Triglyceride, Hydrogenated Rapeseed Oil,

Polymethylsilsesquioxane, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Wax, Butyrospermum Parkii (Shea) Butter,

Gossypium Herbaceum (Cotton) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria)

Flower Extract, Tocopherol, Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Fragrance (Natural)

Section 53413-1

Questions or comments?

Call 760-940-2125

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
  • may stain fabrics
Coola Label

BARE

REPUBLIC​®

Sheer Zinc Oxide

Sunscreen Lotion

0.9 OZ

25 g

©2022 COOLA. Manufactured in the USA for COOLA

LLC, located in sunny San Diego, CA 92009.  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 spectrum SPF 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-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 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

Neopentyl Glycol Diheptanoate, Isododecane, Caprylic/Capric Triglyceride, Hydrogenated Rapeseed Oil,

Polymethylsilsesquioxane, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Wax, Butyrospermum Parkii (Shea) Butter,

Gossypium Herbaceum (Cotton) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria)

Flower Extract, Tocopherol, Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Fragrance (Natural)

Section 53413-1 (53413-1)

Questions or comments?

Call 760-940-2125

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
  • may stain fabrics
Coola Label (COOLA Label)

BARE

REPUBLIC​®

Sheer Zinc Oxide

Sunscreen Lotion

0.9 OZ

25 g

©2022 COOLA. Manufactured in the USA for COOLA

LLC, located in sunny San Diego, CA 92009.  All Rights

Reserved.  WWW.GOBAREOUTSIDE.COM

res


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