FDA.reportPublic FDA data

Bare Republic Mineral Matte Untinted Face Lotion SPF 30

Manufacturer
COOLA, LLC
Effective date
2024-05-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:12:56

Label at a glance#

ProductBare Republic Mineral Matte Untinted Face SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 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 aging caused by the sun

Dosage and administration

Shake well. Apply liberally 15 minutes before sun exposure. Reapply: • after 40 minutes of swimming or sweating • immediately afrer 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: • li...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide - 5.2%

Zinc Oxide - 2.5%

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 aging caused by the sun

WARNINGS SECTION

  • 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 rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well. Apply liberally 15 minutes before sun exposure.
  • Reapply: • after 40 minutes of swimming or sweating • immediately afrer 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

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Isopropyl Myristate, Polyamide-5, Stearalkonium Hectorite, Dimethicone Crosspolymer, Polysilicone-11, Silica Silylate, Aluminum Hydroxide, Hydrogen Dimethicone, Vitis Vinifera (Grape) Seed Oil, Butyrospermum Parkii (Shea) Butter, Daucus Carota Sativa (Carrot) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Call 760-940-2125

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-064-01Bare Republic Mineral Matte Untinted Face SPF 301 in 1 CARTONLOTION13
79753-064-01Bare Republic Mineral Matte Untinted Face SPF 3050 mL in 1 TUBELOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-064BARE REPUBLIC MINERAL MATTE UNTINTED FACE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [COOLA, LLC]3Current NDC, Legacy NDC, 2 package rows20240524_ecabcc89-fb09-41a9-e053-2995a90a8b31.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-06479753-064-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PROPYLENE CARBONATE8D08K3S51EIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
SHEA BUTTERK49155WL9YIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
CARROT SEED OIL595AO13F11IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
POLYAMIDE-5UEM62QMW5FIACT
RASPBERRY SEED OIL9S8867952AIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
GRAPE SEED OIL930MLC8XGGIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ZINC OXIDESOI2LOH54ZACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bare Republic Mineral Matte Untinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCecabcc89-fb09-41a9-e053-2995a90a8b312024-05-22WarningsExact identifier
ndc (package): 79753-064-01
ndc (product): 79753-064
ndc11 (package): 79753006401
spl id: 190e2321-0df9-8ee9-e063-6294a90aff3e
spl set id: ecabcc89-fb09-41a9-e053-2995a90a8b31

Reported adverse events (FAERS/openFDA)#

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