Baby Bare Republic Mineral Sunscreen Stick

Baby Bare Republic Mineral Sunscreen by

Drug Labeling and Warnings

Baby Bare Republic Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Coola, LLC, Gordon Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BABY BARE REPUBLIC MINERAL SUNSCREEN- zinc oxide 24% stick 
Coola, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Baby Bare Republic Mineral Sunscreen Stick

Drug Facts

Active Ingredient

Zinc Oxide 25%

Purpose

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

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.

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

Stop use and ask a doctor if skin rash occurs

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

Directions

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

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

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

Questions or Comments?

Call 760-940-2125

BABY BARE REPUBLIC MINERAL SUNSCREEN 
zinc oxide 24% stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SAFFLOWER OIL (UNII: 65UEH262IS)
COCOA BUTTER (UNII: 512OYT1CRR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CANDELILLA WAX (UNII: WL0328HX19)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLIVE OIL (UNII: 6UYK2W1W1E)
TOCOPHEROL (UNII: R0ZB2556P8)
CERESIN (UNII: Q1LS2UJO3A)
CHAMOMILE (UNII: FGL3685T2X)
AVOCADO OIL (UNII: 6VNO72PFC1)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-003-01	1 in 1 BOX	10/28/2020	12/31/2022
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/28/2020	12/31/2022

Labeler - Coola, LLC (956990290)

Establishment
Name	Address	ID/FEI	Business Operations
Gordon Laboratories, Inc		008328619	manufacture(79753-003)

Revised: 12/2022

Document Id: f0ff6c1c-a2be-11d1-e053-2a95a90adb24

34390-5

Set id: b2bc6741-dd71-1e7c-e053-2995a90adb7b

Version: 2

Effective Time: 20221229

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