Mineral Sunscreen Spf 50

Mineral Sunscreen Spf 50
SPL v1
SPL
SPL Set ID 29e487da-5312-8192-e063-6294a90ad809
Route
TOPICAL
Published
Effective Date 2024-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (19.6 g)
Inactive Ingredients
Methyl Dihydroabietate Theobroma Cacao (cocoa) Seed Butter Water Cetearyl Alcohol Arachidyl Alcohol Bisabolol Butyloctyl Salicylate Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Cetyl Alcohol Citric Acid Cocos Nucifera (coconut) Oil Phenoxyethanol Polyhydroxystearic Acid (2300 Mw) Sodium Gluconate Sodium Hyaluronate Sodium Stearoyl Glutamate Arachidyl Glucoside Ethylhexylglycerin Behenyl Alcohol Butyrospermum Parkii (shea) Butter Cellulose Gum Coco-glucoside Diheptyl Succinate Microcrystalline Cellulose Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-17

Description

Zinc Oxide 19.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 19.6%

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 51945-4

Warnings

• For external use only.

Directions

• 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 valuor higher and other sun protection measures including:

- limit time in the sun, especially from 10 a.m.-2 p.m.

- wear long-sleeved shirts, pants, hats, and sunglasses

• Children under 6 months of age: ask a doctor

• Do Not Use

on damaged or broken skin.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Zinc Oxide 19.6%

Inactive Ingredients

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Ethylhexylglycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water

• 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 right away.


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.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

• For external use only.

Directions

• 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 valuor higher and other sun protection measures including:

- limit time in the sun, especially from 10 a.m.-2 p.m.

- wear long-sleeved shirts, pants, hats, and sunglasses

• Children under 6 months of age: 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.

Active Ingredients (Active ingredients)

Zinc Oxide 19.6%

Inactive Ingredients (Inactive ingredients)

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Ethylhexylglycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water

• 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 right away.


Advanced Ingredient Data


Raw Label Data

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