Coola Bare Republic Mineral Sport Spf50 Lotion

Coola Bare Republic Mineral Sport Spf50 Lotion
SPL v3
SPL
SPL Set ID bbf15e58-c160-d599-e053-2a95a90a0696
Route
TOPICAL
Published
Effective Date 2025-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (78 mg) Titanium Dioxide (29 mg)
Inactive Ingredients
Glycerin Kukui Nut Oil Allyl Heptanoate Isohexadecane Silicon Dioxide Lauryl Peg/ppg-18/18 Methicone Butyloctyl Salicylate Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Coconut Oil Dimethicone Sodium Chloride Triethoxycaprylylsilane Synthetic Beeswax Medium-chain Triglycerides Caprylyl Glycol Ethylhexylglycerin .gamma.-decalactone .gamma.-nonalactone Piperonal Octyldodecyl Citrate Crosspolymer 3-phenyl-1-propanol Alcohol Sodium Citrate .gamma.-octalactone Triethyl Citrate Phymatolithon Calcareum Aloe Vera Leaf Ethylhexyl Methoxycrylene Polyethylene Glycol 4000 4-(p-hydroxyphenyl)-2-butanone .alpha.-tocopherol Acetate Vanillin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-01

Description

Titanium Dioxide 2.9%, Zinc Oxide 7.8

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 2.9%, Zinc Oxide 7.8

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
Label

res

Warnings

For external use only

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

  • children under 6 months of age: 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

Do Not Use
  • on damaged or broken skin.
Other Information
  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Titanium Dioxide 2.9%, Zinc Oxide 7.8

Inactive Ingredients

Alcohol, AleuritesMoluccana (Kukui) Seed Oil, Algae Exract, Allyl Heptoate, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Gamma Decalactone, Gamma Nonalactone, Gamma Octalactone, Glycerin, Heliotropine, Isohecxadecane, Lauryl PEG-8 Dimethicone, Octyldodecyl Citrate Crosspolymer, PEG-8, Phenylpropenol, Raspberry Ketone, Silica, Sodium Chloride, Sodium Citrate, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethyl Citrate, Vanillin, Vegan Beeswax, Water

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs.
Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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
Label

res

Purpose

Sunscreen

Warnings

For external use only

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

  • children under 6 months of age: 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

Do Not Use (Do not use)
  • on damaged or broken skin.
Other Information (Other information)
  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients (Active ingredients)

Titanium Dioxide 2.9%, Zinc Oxide 7.8

Inactive Ingredients

Alcohol, AleuritesMoluccana (Kukui) Seed Oil, Algae Exract, Allyl Heptoate, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Gamma Decalactone, Gamma Nonalactone, Gamma Octalactone, Glycerin, Heliotropine, Isohecxadecane, Lauryl PEG-8 Dimethicone, Octyldodecyl Citrate Crosspolymer, PEG-8, Phenylpropenol, Raspberry Ketone, Silica, Sodium Chloride, Sodium Citrate, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethyl Citrate, Vanillin, Vegan Beeswax, Water

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
Keep Out of the Reach of Children (Keep out of the reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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