Coola Bare Republic Mineral Face Gel-lotion spf 30

Coola Bare Republic Mineral Face Gel-lotion spf 30
SPL v2
SPL
SPL Set ID ad1614d4-5421-473d-a1e8-0ff18491df77
Route
TOPICAL
Published
Effective Date 2021-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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

Water, Caprylic/Capric Triglyceride, Dimethicone, Propylheptyl

Caprylate, Undecane, Methyl Dihydroabietate,

Polyhydroxystearic Acid, Polymethylsilsesquioxane, Tridecane,

Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis

Flower Extract, Aloe Barbadensis Leaf Juice, Butyrospermum

Parkii (Shea) Butter, Olive Oil Polyclyceryl-6 Esters, Melia

Azadirachta Leaf Extract, Melia Azadirachta Flower Extract,

Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant)

Fruit Extract, Curcuma Longa (Turmeric) Root Extract,

Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum

Santcum Leaf Extract, Juniperus Virginiana Oil, Sorbitan

Stearate, Glyceryl Stearate SE, Polyacrylate Crosspolymer-6,

Xanthan Gum, Acrylates Copolymer, Citric Acid,

Methlpropanediol, Polysilicone-11, Caprylyl Glycol, Glycerin,

Sorbityl Laurate, Plyquaternium-80, Corallina Officinalis

Extract, Ethyl Ferulate, Triethoxycaprylylsilane, Lauryl

Glucoside, Didecyldimonium Chloride, Triethyl Citrate, Hexyl

Acetate, Gamma-Nonalactone, Gamma-Octalactone,

Gamma-Undecalactone, Alpha-Ionone, 3-Hexenol, Dimethyl

Heptenal, Decanal

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

Face Gel-Lotion

Sheer, Ultra-Light Hydration

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

1.7 FL OZ / 50 mL

©2022 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

San Diego, CA 92009.

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

Water, Caprylic/Capric Triglyceride, Dimethicone, Propylheptyl

Caprylate, Undecane, Methyl Dihydroabietate,

Polyhydroxystearic Acid, Polymethylsilsesquioxane, Tridecane,

Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis

Flower Extract, Aloe Barbadensis Leaf Juice, Butyrospermum

Parkii (Shea) Butter, Olive Oil Polyclyceryl-6 Esters, Melia

Azadirachta Leaf Extract, Melia Azadirachta Flower Extract,

Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant)

Fruit Extract, Curcuma Longa (Turmeric) Root Extract,

Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum

Santcum Leaf Extract, Juniperus Virginiana Oil, Sorbitan

Stearate, Glyceryl Stearate SE, Polyacrylate Crosspolymer-6,

Xanthan Gum, Acrylates Copolymer, Citric Acid,

Methlpropanediol, Polysilicone-11, Caprylyl Glycol, Glycerin,

Sorbityl Laurate, Plyquaternium-80, Corallina Officinalis

Extract, Ethyl Ferulate, Triethoxycaprylylsilane, Lauryl

Glucoside, Didecyldimonium Chloride, Triethyl Citrate, Hexyl

Acetate, Gamma-Nonalactone, Gamma-Octalactone,

Gamma-Undecalactone, Alpha-Ionone, 3-Hexenol, Dimethyl

Heptenal, Decanal

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

Face Gel-Lotion

Sheer, Ultra-Light Hydration

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

1.7 FL OZ / 50 mL

©2022 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool

San Diego, CA 92009.

WWW.GOBAREOUTSIDE.COM

res


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