FDA.reportPublic FDA data

Bare Republic Sheer Zinc Oxide Sunscreen Lotion

Manufacturer
COOLA LLC
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:06

Label at a glance#

ProductBare Republic Mineral SPF 50
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Zinc Oxide 17.9%

OTC - PURPOSE SECTION

Purpose

Suncreen

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - STOP USE SECTION

Stop use and ask doctor if skin 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.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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)

OTHER SAFETY INFORMATION

Other information

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

OTC - QUESTIONS SECTION

Questions or comments?
Call 760-940-2125

COOLA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Bare Outer 069Bare Outer 069

Bare Inner 069Bare Inner 069

res

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-069-01Bare Republic Mineral SPF 501 in 1 CARTONSTICK13
79753-069-01Bare Republic Mineral SPF 5025 g in 1 CANISTERSTICK253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-069BARE REPUBLIC MINERAL SPF 50 (ZINC OXIDE) STICK [COOLA LLC]3Current NDC, 2 package rows20241228_6a0db9da-ee45-4ab7-80de-4bf189efe75f.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-06979753-069-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
ISODODECANEA8289P68Y2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HYDROGENATED RAPESEED OILK168T6Y0YUIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
STEARYL ALCOHOL2KR89I4H1YIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYL FERULATE5B8915UELWIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT
SHEA BUTTERK49155WL9YIACT
LEVANT COTTONSEED OILN5CFT140R8IACT
SAFFLOWER OIL65UEH262ISIACT
CHAMOMILEFGL3685T2XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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 SPF 50ZINC OXIDECOOLA LLC6a0db9da-ee45-4ab7-80de-4bf189efe75f2024-12-27WarningsExact identifier
ndc (package): 79753-069-01
ndc (product): 79753-069
ndc11 (package): 79753006901
spl id: 248f3fea-824b-412c-a0c5-4c40619d17ba
spl set id: 6a0db9da-ee45-4ab7-80de-4bf189efe75f

Reported adverse events (FAERS/openFDA)#

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