BARE BARRIER SPORT- titanium dioxide, zinc oxide cream

Bare Barrier Sport by

Drug Labeling and Warnings

Bare Barrier Sport by is a Otc medication manufactured, distributed, or labeled by Skin Apeel, Inc., Custom Analytics LLC, Fragrance Manufacturing Inc., Fallien Cosmeceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose:

Sunscreen

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.

Warnings:

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Warnings:

Keep out of reach of children

Directions:

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. 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 value 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-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients:

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

• Protect this product from excessive heat and direct sun
• May stain some fabrics

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BARE BARRIER SPORT 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83628-258(NDC:58892-258)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CI 77499 (UNII: XM0M87F357)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
CETEARETH-20 (UNII: YRC528SWUY)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CI 77492 (UNII: EX438O2MRT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CI 77491 (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ISOHEXADECANE (UNII: 918X1OUF1E)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83628-258-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/28/2025

Labeler - Skin Apeel, Inc. (840716328)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(83628-258)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(83628-258)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(83628-258)