Mustela Mineral Sunscreen Spray Broad Spectrum Spf 50

Mustela Mineral Sunscreen Spray Broad Spectrum Spf 50
SPL v5
SPL
SPL Set ID beec926c-35a5-1901-e053-2a95a90ad043
Route
TOPICAL
Published
Effective Date 2021-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (147 mg) Titanium Dioxide (43 mg)
Inactive Ingredients
Heptyl Undecylenate Methyl Dihydroabietate Cetostearyl Alcohol Bentonite Caprylyl Glycol Coco Glucoside Aluminum Oxide Sodium Gluconate Caprylhydroxamic Acid Glycerin Citric Acid Monohydrate Chamomile Polyhydroxystearic Acid (2300 Mw) Levomenol Nasturtium Officinale Flowering Top Sunflower Oil Filipendula Ulmaria Flower Calendula Officinalis Flower Carboxymethylcellulose Sodium, Unspecified Form Tocopherol Water Olive Oil Coconut Oil Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Butyloctyl Salicylate Aloe Vera Leaf Propanediol Sodium Stearoyl Glutamate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Titanium Dioxide 4.3% Zinc Oxide 14.7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 4.3% Zinc Oxide 14.7%

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

For external use only

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Directions
  • Shake well before use
  • Hold container 4 to 6 inches from the skin to apply
  • Apply liberally 15 minutes before sun exposure
  • Do not spray directly into face
  • Do not spray in windy condition
  • Use in well-ventilated area
  • 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 protection measures including:
  • Limit time in the sun, especially from 10 a.m - 2p.m
  • Wear long-sleeved shirt, pants, hat, and sunglasses
  • Children under 6 months: ask a doctor.
Do Not Use

on damaged or broken skin

Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.
Product Packaging

Active Ingredients

Titanium Dioxide 4.3%

Zinc Oxide 14.7%

Company Information

MADE IN THE USA from globally sourced materials for

Expanscience Laboratories Inc.,

Dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022

www.MustelaUSA.com

Inactive Ingredients

Water, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydroabietate, Cetearyl Alcohol, Propanediol, Sodium Stearoyl Glutamate, Bentonite, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Bisabolol*, Alumina, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Silica, Cellulose Gum, Aloe Barbadensis Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Spiraea Ulmaria Flower Extract*, Nasturtium Officinale Flower/Leaf Extract*, *Certified Organic Ingredients

Questions Or Comments?

Call toll free 1-800-422-2987

Monday-Friday 9:00am-5:00pm EST

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 Reach of Children.

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


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.
Purpose

Sunscreen

Warnings

For external use only

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Directions
  • Shake well before use
  • Hold container 4 to 6 inches from the skin to apply
  • Apply liberally 15 minutes before sun exposure
  • Do not spray directly into face
  • Do not spray in windy condition
  • Use in well-ventilated area
  • 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 protection measures including:
  • Limit time in the sun, especially from 10 a.m - 2p.m
  • Wear long-sleeved shirt, pants, hat, and sunglasses
  • Children under 6 months: ask a doctor.
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 some fabrics.
Product Packaging

Active Ingredients (Active ingredients)

Titanium Dioxide 4.3%

Zinc Oxide 14.7%

Company Information

MADE IN THE USA from globally sourced materials for

Expanscience Laboratories Inc.,

Dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022

www.MustelaUSA.com

Inactive Ingredients (Inactive ingredients)

Water, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydroabietate, Cetearyl Alcohol, Propanediol, Sodium Stearoyl Glutamate, Bentonite, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Bisabolol*, Alumina, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Silica, Cellulose Gum, Aloe Barbadensis Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Spiraea Ulmaria Flower Extract*, Nasturtium Officinale Flower/Leaf Extract*, *Certified Organic Ingredients

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-422-2987

Monday-Friday 9:00am-5:00pm EST

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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


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Raw Label Data

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