Coola Mineral Spray Spf 30 - Unscented

Coola Mineral Spray Spf 30 - Unscented
SPL v2
SPL
SPL Set ID edc6048e-0ea0-41c5-e053-2a95a90a96d9
Route
TOPICAL
Published
Effective Date 2022-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (14.5 g)
Inactive Ingredients
Laminaria Digitata Bentonite Camelina Sativa Seed Oil Caprylhydroxamic Acid Citric Acid Monohydrate Sunflower Oil Levomenol Brassica Rapa Subsp. Oleifera Oil Carthamus Tinctorius (safflower) Oleosomes Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Form Sodium Stearoyl Glutamate Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Water Cetostearyl Alcohol Shea Butter Ethyl Esters Propanediol Aloe Vera Leaf Rosemary Orange Butyloctyl Salicylate Methyl Dihydroabietate Coco Glucoside Glycerin Meadowfoam Seed Oil Caprylyl Glycol Jojoba Oil Coconut Oil Mauritia Flexuosa Fruit Oil Raspberry Seed Oil Opuntia Ficus-indica Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-01

Description

Zinc Oxide - 14.5%


Medication Information

Warnings and Precautions
  • For external use only
  • Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. Do not use in the presence of a flame or spark, or while smoking.
  • Do not use on damaged or broken skin
  • When using this product keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as could cause surface to become slippery. Do not apply in windy conditions. Use in a well ventilated area.
  • Stop use and ask doctor if skin rash occurs
Description

Zinc Oxide - 14.5%

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.

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

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), WaterSimmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil (ORGANIC), Methyl Dihydroabietate, Bentonite, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Opuntia Ficus-Indica Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Shea Butter Ethyl Esters, Propanediol, Glycerin (ORGANIC), Coco-Glucoside, Laminaria Digitata (Algae) Extract (ORGANIC), Microcrystalline Cellulose, Cellulose Gum, Sodium Stearoyl Glutamate, Caprylhydroxamic Acid, Caprylyl Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Citric Acid

Section 51945-4

Section 53413-1

Call 760-940-2125

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide - 14.5%

Section 60561-8
  • May stain fabrics
  • Protect this product from excessive heat and direct sun
Directions

• Shake well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. • When properly used, mineral sunscreens will leave a whitish tint when first applied.

• Reapply: • after 80 minutes of swimming or sweating • immediately afrer 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


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.

Warnings and Precautions (34071-1)
  • For external use only
  • Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. Do not use in the presence of a flame or spark, or while smoking.
  • Do not use on damaged or broken skin
  • When using this product keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as could cause surface to become slippery. Do not apply in windy conditions. Use in a well ventilated area.
  • Stop use and ask doctor if skin rash occurs
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)

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), WaterSimmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil (ORGANIC), Methyl Dihydroabietate, Bentonite, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Opuntia Ficus-Indica Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Shea Butter Ethyl Esters, Propanediol, Glycerin (ORGANIC), Coco-Glucoside, Laminaria Digitata (Algae) Extract (ORGANIC), Microcrystalline Cellulose, Cellulose Gum, Sodium Stearoyl Glutamate, Caprylhydroxamic Acid, Caprylyl Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Citric Acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 760-940-2125

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide - 14.5%

Section 60561-8 (60561-8)
  • May stain fabrics
  • Protect this product from excessive heat and direct sun
Directions

• Shake well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. • When properly used, mineral sunscreens will leave a whitish tint when first applied.

• Reapply: • after 80 minutes of swimming or sweating • immediately afrer 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


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