FDA.reportPublic FDA data

Bare Republic Big Adventure Stick SPF 70

Manufacturer
COOLA | Bentley Laboratories, LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:18

Label at a glance#

ProductBare Republic Big Adventure Stick SPF 70
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Titanium Dioxide 3.5%   Zinc Oxide 16.9%

OTC - PURPOSE SECTION

Purpose
Sunscreen

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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 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 after 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

Helianthus Annuus (Sunflower) Seed Wax,
Neopentyl Glycol Diheptanoate, C12-15 Alkyl
Benzoate, Isododecane, Behenyl Behenate,
Caprylic/Capric Triglyceride, Lauryl Laurate,
Polyhydroxystearic Acid, Butyrospermum Parkii
(Shea) Butter, Ethylhexyl Methoxycrylene, Methyl
Dihydroabietate, Stearyl/Octyldodecyl Citrate
Crosspolymer, Polymethylsilsesquioxane,
Trimethoxybenzylidene Pentanedione, Triethyl
Citrate, Ethyl Ferulate, Triethoxycaprylylsilane,
1,2-Hexanediol, Caprylyl Glycol, Euphorbia Cerifera
(Candelilla) Wax, Stearic Acid, Alumina,
Gamma-Decalactone, Raspberry Ketone, Isostearic
Acid, Vanillin, Gamma-Nonalactone, Gamma
Octalactone, Lecithin, Polyglyceryl-3 Polyricinoleate,
Allyl Heptoate, Heliotropine, Vitis Vinifera (Grape)
Seed Extract, Daucus Carota Sativa (Carrot) Root
Extract, Rubus Idaeus (Raspberry) Fruit Extract.

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

Package for BARE REPUBLIC MINERAL Sunscreen Stick

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 70

BARE

REPUBLIC ​®

MINERAL

Sunscreen Stick

2.0 OZ / 56 g

Distributed by:

COOLA LLC, Located in Sunny &

Cool San Diego, CA 92009.

WWW.GOBAREOUTSIDE.COM

COOLA-026COOLA-026

res

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-026-01Bare Republic Big Adventure Stick SPF 7056 g in 1 TUBESTICK562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-026BARE REPUBLIC BIG ADVENTURE STICK SPF 70 (TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%) STICK [COOLA]2Current NDC, Legacy NDC, 1 package rows20231221_e800f72f-8c8b-4a12-843f-1ee404055cf0.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-02679753-026-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISODODECANEA8289P68Y2IACT
BEHENYL BEHENATEK8NU647RJ0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LAURYL LAURATEGPW77G0937IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SHEA BUTTERK49155WL9YIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
TRIMETHOXYBENZYLIDENE PENTANEDIONE322V0ACF25IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
ETHYL FERULATE5B8915UELWIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CANDELILLA WAXWL0328HX19IACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
.GAMMA.-DECALACTONE7HLS05KP9OIACT
4-(P-HYDROXYPHENYL)-2-BUTANONE7QY1MH15BGIACT
ISOSTEARIC ACIDX33R8U0062IACT
VANILLINCHI530446XIACT
.GAMMA.-NONALACTONEI1XGH66S8PIACT
.GAMMA.-OCTALACTONEUHD6M52X0KIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ALLYL HEPTANOATEAU4CYG9V68IACT
PIPERONALKE109YAK00IACT
VITIS VINIFERA SEEDC34U15ICXAIACT
CARROTL56Z1JK48BIACT
RASPBERRY4N14V5R27WIACT

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 Big Adventure Stick SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%COOLAe800f72f-8c8b-4a12-843f-1ee404055cf02023-12-20WarningsExact identifier
ndc (package): 79753-026-01
ndc (product): 79753-026
ndc11 (package): 79753002601
spl id: 8246c27d-f27a-4a31-9e5a-7ebd44ce81ef
spl set id: e800f72f-8c8b-4a12-843f-1ee404055cf0

Reported adverse events (FAERS/openFDA)#

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