Mustela Mineral Sunscreen Broad Spectrum Spf 50

Mustela Mineral Sunscreen Broad Spectrum Spf 50
SPL v6
SPL
SPL Set ID 95ea5442-a7ca-0c7d-e053-2a95a90ad247
Route
TOPICAL
Published
Effective Date 2019-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (240 mg)
Inactive Ingredients
Water Glycerin Polyglyceryl-3 Ricinoleate Medium-chain Triglycerides Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Propanediol 1,2-hexanediol Magnesium Sulfate, Unspecified Form Sodium Chloride Caprylhydroxamic Acid Hyaluronate Sodium Malic Acid Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone C15-19 Alkane Ethyl Macadamiate Stearyl/octyldodecyl Citrate Crosspolymer Triethoxycaprylylsilane Polyhydroxystearic Acid (2300 Mw) Hydroxyacetophenone .alpha.-tocopherol Acetate .alpha.-tocopherol, D-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-01 Until 2025-11-30

Description

Zinc Oxide 24%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 24%

Uses
  • Helps prevent sunburn
  • If used as directed wtih 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 swallowed, get medical help or contact a Poison Control center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of the eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Warnings

For external use only.

Directions
  • Apply liberally to exposed areas 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, expecially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirt, pants, hat and sunglasses
  • children under 6 months: ask a doctor
Active Ingredient

Zinc Oxide 24%

Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.
  • You may report a serious adverse event to the phone number or address provided below.
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, C15-19 ALKANE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYL MACADAMIATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STYRENE/ACRYLATES COPOLYMER, STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, SODIUM CHLORIDE, CAPRYLHYDROXAMIC ACID, TOCOPHERYL ACETATE, SODIUM HYALURONATE, TOCOPHEROL, MALIC ACID

Questions Or Comments?

Call toll free 1-800-422-2987 Monday-Friday 9:00am - 5:00pm EST

Product Packaging 100ml


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed wtih other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of the eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Apply liberally to exposed areas 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, expecially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirt, pants, hat and sunglasses
  • children under 6 months: ask a doctor
Active Ingredient

Zinc Oxide 24%

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.
  • You may report a serious adverse event to the phone number or address provided below.
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, C15-19 ALKANE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYL MACADAMIATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STYRENE/ACRYLATES COPOLYMER, STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, SODIUM CHLORIDE, CAPRYLHYDROXAMIC ACID, TOCOPHERYL ACETATE, SODIUM HYALURONATE, TOCOPHEROL, MALIC ACID

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-422-2987 Monday-Friday 9:00am - 5:00pm EST

Product Packaging 100ml (Product Packaging - 100ml)


Advanced Ingredient Data


Raw Label Data

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