FDA.reportPublic FDA data

Bare Barrier Sport

Manufacturer
Skin Apeel, Inc. | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:12

Label at a glance#

ProductBare Barrier Sport
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Indications and 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

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 inclu...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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:

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130383628258504GTIN-13: 0383628258504
EAN-13: 0383628258504
GTIN-12: 383628258504
UPC-A: 383628258504
GTIN storage (14 digits): 00383628258504		APEEL 258.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83628-258-50Bare Barrier Sport53 g in 1 BOTTLE, PUMPCREAM532

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83628-25883628-258-50
58892-258

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
CI 77499XM0M87F357IACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
CETEARETH-20YRC528SWUYIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CI 77492EX438O2MRTIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GLYCERINPDC6A3C0OXIACT
ISODODECANEA8289P68Y2IACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
ETHYLHEXYL HYDROXYSTEARATE BENZOATE3W8F25684BIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CI 774911K09F3G675IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
TRIETHANOLAMINE9O3K93S3TKIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ISOHEXADECANE918X1OUF1EIACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bare Barrier SportTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c580794-eda3-de57-e063-6294a90a03032025-12-08WarningsExact identifier
ndc (package): 83628-258-50
ndc (product): 83628-258
ndc11 (package): 83628025850
spl id: 457665db-6a85-cba2-e063-6294a90aee9b
spl set id: 3c580794-eda3-de57-e063-6294a90a0303
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
ndc (product): 58892-258

Reported adverse events (FAERS/openFDA)#

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