Coola Bare Republic Mineral Face Lotion Spf 70

Coola Bare Republic Mineral Face Lotion Spf 70
SPL v2
SPL
SPL Set ID a334a61d-5c5a-4f45-b202-6dd7bb3d250b
Route
TOPICAL
Published
Effective Date 2023-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (15.8 g) Titanium Dioxide (3.5 g)
Inactive Ingredients
Allyl Heptanoate Benzyl Alcohol Butyrospermum Parkii (shea) Butter Unsaponifiables C20-22 Alcohols C20-22 Alkyl Phosphate Caprylhydroxamic Acid Medium-chain Triglycerides Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Cetostearyl Alcohol Coco-caprylate/caprate Coco Glucoside Carrot Dimethicone Ethylhexyl Methoxycrylene .gamma.-decalactone .gamma.-nonalactone .gamma.-octalactone Glycerin Piperonal 1,2-hexanediol Isostearic Acid Lauryl Laurate Lecithin, Sunflower Methyl Dihydroabietate Microcrystalline Cellulose Polyglyceryl-3 Pentaricinoleate Polyhydroxystearic Acid (2300 Mw) 4-(p-hydroxyphenyl)-2-butanone Rubus Idaeus Leaf Sodium Hydroxide Disodium Phthalate Stearic Acid Stearyl/octyldodecyl Citrate Crosspolymer Triethyl Citrate Vanillin Vitis Vinifera Seed Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-01

Description

Drug Facts Active Ingredients Titanium Dioxide 3.5% Zinc Oxide 15.8%


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 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

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 Titanium Dioxide 3.5% Zinc Oxide 15.8%

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

Allyl Heptoate, Alumina, Benzyl Alcohol,

Butyrospermum Parkii (Shea) Butter, C20-22

Alcohols, C20-22 Alkyl Phosphate, Calcium

Starch Octenylsuccinate, Caprylhydroxamic

Acid, Caprylic/Capric Triglyceride, Caprylyl

Glycol, Cellulose Gum, Cetearyl Alcohol,

Coco-Caprylate/Caprate, Coco-Glucoside,

Daucus Carota Sativa (Carrot) Root Extract,

Dimethicone, Ethylhexyl Methoxycrylene,

Gamma-Decalactone, Gamma-Nonalactone,

Gamma-Octalactone, Glycerin, Heliotropine,

1,2-Hexanediol, Isostearic Acid, Lauryl Laurate,

Lecithin, Methyl Dihydroabietate,

Microcrystalline Cellulose, Polyglyceryl-3

Polyricinoleate, Polyhydroxystearic Acid,

Raspberry Ketone, Rubus Idaeus (Raspberry)

Leaf Extract, Sodium Hydroxide, Sodium

Phytate, Stearic Acid, Stearyl/Octyldodecyl

Citrate Crosspolymer, Triethyl Citrate, Vanillin,

Vitis Vinifera (Grape) Seed Extract, Water



Section 55105-1

Purpose

Suncreen

Section 55106-9

Drug Facts

Active Ingredients

Titanium Dioxide 3.5%

Zinc Oxide 15.8%

Section 60561-8

Other information

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

SPF

70

BARE

REPUBLIC

MINERAL

Sunscreen Lotion

Non-Nano Zinc Oxide

Face

Sheer, Oil-Free Finish

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

2.0 FL OZ / 59 mL

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

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

San Diego, CA 92010.

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 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

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

Allyl Heptoate, Alumina, Benzyl Alcohol,

Butyrospermum Parkii (Shea) Butter, C20-22

Alcohols, C20-22 Alkyl Phosphate, Calcium

Starch Octenylsuccinate, Caprylhydroxamic

Acid, Caprylic/Capric Triglyceride, Caprylyl

Glycol, Cellulose Gum, Cetearyl Alcohol,

Coco-Caprylate/Caprate, Coco-Glucoside,

Daucus Carota Sativa (Carrot) Root Extract,

Dimethicone, Ethylhexyl Methoxycrylene,

Gamma-Decalactone, Gamma-Nonalactone,

Gamma-Octalactone, Glycerin, Heliotropine,

1,2-Hexanediol, Isostearic Acid, Lauryl Laurate,

Lecithin, Methyl Dihydroabietate,

Microcrystalline Cellulose, Polyglyceryl-3

Polyricinoleate, Polyhydroxystearic Acid,

Raspberry Ketone, Rubus Idaeus (Raspberry)

Leaf Extract, Sodium Hydroxide, Sodium

Phytate, Stearic Acid, Stearyl/Octyldodecyl

Citrate Crosspolymer, Triethyl Citrate, Vanillin,

Vitis Vinifera (Grape) Seed Extract, Water



Section 55105-1 (55105-1)

Purpose

Suncreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Titanium Dioxide 3.5%

Zinc Oxide 15.8%

Section 60561-8 (60561-8)

Other information

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

SPF

70

BARE

REPUBLIC

MINERAL

Sunscreen Lotion

Non-Nano Zinc Oxide

Face

Sheer, Oil-Free Finish

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

2.0 FL OZ / 59 mL

*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free

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

San Diego, CA 92010.

res


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