Mustela Mineral Sunscreen Face+body Spf50

Mustela Mineral Sunscreen Face+body Spf50
SPL v2
SPL
SPL Set ID bbeffa0a-2bc9-fea4-e053-2a95a90ac511
Route
TOPICAL
Published
Effective Date 2021-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24 mg)
Inactive Ingredients
Water Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Sodium Chloride Glycerin Triethoxycaprylylsilane Magnesium Sulfate, Unspecified Caprylic/capric/lauric Triglyceride Stearyl/octyldodecyl Citrate Crosspolymer Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Polyhydroxystearic Acid (2300 Mw) C15-19 Alkane Polyglyceryl-3 Ricinoleate Ethyl Macadamiate Propanediol 1,2-hexanediol Hydroxyacetophenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-02-22 Until 2023-02-10

Description

Zinc Oxide 24%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps to prevent the 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

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.

Description

Zinc Oxide 24%

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.

Section 51727-6

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

Section 51945-4

Section 53413-1

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

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 24%

Section 60561-8

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.


Structured Label Content

Indications and Usage (34067-9)

Helps to prevent the 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)

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.

Warnings and Precautions (34071-1)

For external use only.

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 24%

Section 60561-8 (60561-8)

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.


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