Coola Bare Republic Mineral Body Gel Lotion Spf 30

Coola Bare Republic Mineral Body Gel Lotion Spf 30
SPL v2
SPL
SPL Set ID d745d12e-8741-4bf2-89ec-c6f72a8d548b
Route
TOPICAL
Published
Effective Date 2021-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (18.2 g)
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Aloe Vera Flower Aloe Vera Leaf .alpha.-ionone Shea Butter Calendula Officinalis Flower Medium-chain Triglycerides Caprylyl Glycol Citric Acid Monohydrate Coccinia Grandis Fruit Corallina Officinalis Turmeric Carrot Seed Oil Decanal .delta.-dodecalactone Didecyldimonium Chloride Dimethicone 2,6-dimethyl-5-heptenal Ethyl Ferulate .gamma.-nonalactone .gamma.-octalactone .gamma.-undecalactone Glyceryl Stearate Se Sunflower Oil 3-hexen-1-ol, (3z)- Hexyl Acetate Juniperus Virginiana Oil Lauryl Glucoside Azadirachta Indica Flower Azadirachta Indica Leaf Methyl Dihydroabietate Methylpropanediol Ocimum Basilicum Flowering Top Holy Basil Leaf Olive Oil Polyglyceryl-6 Esters Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Polyhydroxystearic Acid (2300 Mw) Polymethylsilsesquioxane (4.5 Microns) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Propylheptyl Caprylate Raspberry Seed Oil Eggplant Sorbitan Monostearate Sorbityl Laurate Tridecane Triethoxycaprylylsilane Triethyl Citrate Undecane Grape Seed Oil Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-02

Description

Drug Facts Active Ingredients Zinc Oxide 18.2%


Medication Information

Warnings and Precautions

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.

Stop use and ask doctor if skin rash occurs

Indications and Usage

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

Dosage and Administration

Directions

● Shake well. Apply liberally 15 minutes before sun exposure

● reapply:

  ● after 40 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

Description

Drug Facts Active Ingredients Zinc Oxide 18.2%

Section 42229-5

Questions or comments?

Call 760-940-2125

Section 50565-1

Keep out of reach of children.  If product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients

Acrylates Copolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, Alpha-Ionone*,

Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Caprylic/capric Triglyceride,

Caprylyl Glycol, Citric Acid, Coccinia Indica Fruit Extract, Corallina Officinalis Extract, Curcuma Longa

(Turmeric) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Decanal*, Delta-Dodecalactone*,

Didecyldimonium Chloride, Dimethicone, Dimethyl Heptenal*, Ethyl Ferulate, Gamma-Nonalactone*,

Gamma-Octalactone*, Gamma-Undecalactone*, Glyceryl Stearate SE, Helianthus Annuus (Sunflower)

Seed Oil, 3-Hexenol*, Hexyl Acetate*, Juniperus Virginiana Oil*, Lauryl Glucoside, Melia Azadirachta Flower

Extract, Melia Azadirachta Leaf Extract, Methyl Dihydroabietate, Methlypropanediol, Ocimum Basilicum

(Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Olive Oil Polyglyceryl-6 Esters, Polyacrylate

Crosspolymer-6, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polyquaternium-80, Polysilicone-11,

Propylheptyl Caprylate, Rubus Idaeus (Raspberry) Seed Oil, Solanum Melongena (Eggplant) Fruit Extract,

Sorbitan Stearate, Sorbityl Laurate, Tridecane, Triethoxycaprylylsilane, Triethyl Citrate*, Undecane, Vitis

Vinifera (Grape) Seed Oil, Water, Xanthan Gum



Section 55105-1

Purpose

Suncreen

Section 55106-9

Drug Facts

Active Ingredients

Zinc Oxide 18.2%

Section 60561-8

Other information

  • protect this product from excessive heat and direct sun
Coola Label

SPF

30

BARE

REPUBLIC

MINERAL

Sunscreen

Non-Nano Zinc Oxide

Gel-Lotion

Sheer, Ultra-Light Hydration

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

4.0 FL OZ / 118 mL

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

San Diego, CA 92010.

WWW.GOBAREOUTSIDE.COM

res


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

● Shake well. Apply liberally 15 minutes before sun exposure

● reapply:

  ● after 40 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

Warnings and Precautions (34071-1)

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.

Stop use and ask doctor if skin rash occurs

Section 42229-5 (42229-5)

Questions or comments?

Call 760-940-2125

Section 50565-1 (50565-1)

Keep out of reach of children.  If product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients

Acrylates Copolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, Alpha-Ionone*,

Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Caprylic/capric Triglyceride,

Caprylyl Glycol, Citric Acid, Coccinia Indica Fruit Extract, Corallina Officinalis Extract, Curcuma Longa

(Turmeric) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Decanal*, Delta-Dodecalactone*,

Didecyldimonium Chloride, Dimethicone, Dimethyl Heptenal*, Ethyl Ferulate, Gamma-Nonalactone*,

Gamma-Octalactone*, Gamma-Undecalactone*, Glyceryl Stearate SE, Helianthus Annuus (Sunflower)

Seed Oil, 3-Hexenol*, Hexyl Acetate*, Juniperus Virginiana Oil*, Lauryl Glucoside, Melia Azadirachta Flower

Extract, Melia Azadirachta Leaf Extract, Methyl Dihydroabietate, Methlypropanediol, Ocimum Basilicum

(Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Olive Oil Polyglyceryl-6 Esters, Polyacrylate

Crosspolymer-6, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polyquaternium-80, Polysilicone-11,

Propylheptyl Caprylate, Rubus Idaeus (Raspberry) Seed Oil, Solanum Melongena (Eggplant) Fruit Extract,

Sorbitan Stearate, Sorbityl Laurate, Tridecane, Triethoxycaprylylsilane, Triethyl Citrate*, Undecane, Vitis

Vinifera (Grape) Seed Oil, Water, Xanthan Gum



Section 55105-1 (55105-1)

Purpose

Suncreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Zinc Oxide 18.2%

Section 60561-8 (60561-8)

Other information

  • protect this product from excessive heat and direct sun
Coola Label (COOLA Label)

SPF

30

BARE

REPUBLIC

MINERAL

Sunscreen

Non-Nano Zinc Oxide

Gel-Lotion

Sheer, Ultra-Light Hydration

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

4.0 FL OZ / 118 mL

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

San Diego, CA 92010.

WWW.GOBAREOUTSIDE.COM

res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)