Spf30 Premium Mineral Sunscreen Lotion

Spf30 Premium Mineral Sunscreen Lotion
SPL v3
SPL
SPL Set ID bba219a4-de83-76fd-e053-2995a90a2d69
Route
TOPICAL
Published
Effective Date 2021-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (188 mg)
Inactive Ingredients
Octyldodecanol Polyhydroxystearic Acid (2300 Mw) Cucumis Sativus Whole Zingiber Officinale Whole Xanthan Gum Tetrasodium Glutamate Diacetate Caprylhydroxamic Acid Water Coco-caprylate/caprate Steareth-2 Steareth-21 Propanediol Sodium Hydroxide Glycerin Helianthus Annuus Whole Simmondsia Chinensis Seed Cetyl Glyceryl Ether Sodium Stearoyl Glutamate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-19

Description

SPF30 Premium Mineral Sunscreen Lotion


Medication Information

Warnings and Precautions

WARNINGS:

- For external use only.

Indications and Usage

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. 

Dosage and Administration

DIRECTIONS:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

- Children under 6 months of age: ask a doctor

- 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 value of 15 or higher and other sun protection measures including:

-limit your time in the sun, especially from 10am-2pm

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

Description

SPF30 Premium Mineral Sunscreen Lotion

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 eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

INACTIVE INGREDIENTS:

Water (Aqua), Coco-Caprylate/Caprate, Glycerin, Steareth-2, Octyldodecanol, Steareth-21, Propanediol, Cetearyl Alcohol, Polyhydroxystearic Acid, Cucumis Sativus (Cucumber) Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Bisabolol, Cetyl Glyceryl Ether, Sodium Stearoyl Glutamate, Xanthan Gum, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Sodium Hydroxide

Section 51945-4

Section 55105-1

PURPOSE: Sunscreen

Section 55106-9

ACTIVE INGREDIENT: Zinc Oxide, 18.8%

Section 69718-5

SPF30 Premium Mineral Sunscreen Lotion


Structured Label Content

Indications and Usage (34067-9)

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. 

Dosage and Administration (34068-7)

DIRECTIONS:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

- Children under 6 months of age: ask a doctor

- 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 value of 15 or higher and other sun protection measures including:

-limit your time in the sun, especially from 10am-2pm

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

Warnings and Precautions (34071-1)

WARNINGS:

- 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 eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:

Water (Aqua), Coco-Caprylate/Caprate, Glycerin, Steareth-2, Octyldodecanol, Steareth-21, Propanediol, Cetearyl Alcohol, Polyhydroxystearic Acid, Cucumis Sativus (Cucumber) Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Bisabolol, Cetyl Glyceryl Ether, Sodium Stearoyl Glutamate, Xanthan Gum, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Sodium Hydroxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE: Sunscreen

Section 55106-9 (55106-9)

ACTIVE INGREDIENT: Zinc Oxide, 18.8%

Section 69718-5 (69718-5)

SPF30 Premium Mineral Sunscreen Lotion


Advanced Ingredient Data


Raw Label Data

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