FDA.reportPublic FDA data

Baby Bare Republic Mineral Sunscreen SoftStick SPF 50

Manufacturer
COOLA LLC | Bentley Laboratories, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:54

Label at a glance#

ProductBaby Bare Republic Mineral Sunscreen SoftStick 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 spection SPF of 15 or higher and other sun protection
measures including: SPF of 15 or higher and other sun protection
● 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 IngredientsButyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethyl Ferulate, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Isododecane, Neopentyl Glycol Diheptanoate, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Stearyl Alcohol, Tocopherol, Triethoxycaprylylsilane

OTHER SAFETY INFORMATION

Other information

  • protect this product from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Questions or comments?
Call 760-940-2125

COOLA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BABY BARE

REPUBLIC

MINERAL SUNSCREEN

Softstick

0.9 OZ / 25 g

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

San Diego, CA 92010. All Rights Reserved.

WWW.GOBAREOUTSIDE.COM


BabyBareBabyBare

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
79753-009-01Baby Bare Republic Mineral Sunscreen SoftStick SPF 501 in 1 BLISTER PACKSTICK12
79753-009-01Baby Bare Republic Mineral Sunscreen SoftStick SPF 5025 g in 1 CANISTERSTICK252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-009BABY BARE REPUBLIC MINERAL SUNSCREEN SOFTSTICK SPF 50 (ZINC OXIDE) STICK [COOLA LLC]2Current NDC, Legacy NDC, 2 package rows20231220_1a603f62-86ec-4e66-a73f-718c5d012676.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-00979753-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERSR2Z4507WJNIACT
CHAMOMILEFGL3685T2XIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYL FERULATE5B8915UELWIACT
COTTONSEED OILH3E878020NIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
HYDROGENATED RAPESEED OILK168T6Y0YUIACT
ISODODECANEA8289P68Y2IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
STEARYL ALCOHOL2KR89I4H1YIACT
TOCOPHEROLR0ZB2556P8IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT

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
Baby Bare Republic Mineral Sunscreen SoftStick SPF 50ZINC OXIDECOOLA LLC1a603f62-86ec-4e66-a73f-718c5d0126762023-12-19WarningsExact identifier
ndc (package): 79753-009-01
ndc (product): 79753-009
ndc11 (package): 79753000901
spl id: 7a1f9caf-7887-4f00-80f6-5f74db74c4ef
spl set id: 1a603f62-86ec-4e66-a73f-718c5d012676

Reported adverse events (FAERS/openFDA)#

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