SPL v2
SPL
SPL Set ID 759f439b-aba5-4cdf-91c4-1774cd911182
Route
TOPICAL
Published
Effective Date 2024-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Zinc Oxide 20%                                   Sunscreen


Medication Information

Indications and Usage

•helps prevent sunburn• If used as directed with other sun protection measures ( see Oirections ),decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

• apply liberally 15 minutes before sun exposure and as needed. Reapply: after 40 minutes of sweeming or sweating immidiately after towel drying at least every 2 hours.  Sun Protection Measure s. Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly usea sunscreen wrtha Broad Spectrum SPF value of15 or higher and other suncrin protection measures including: • limrt time in the sun, especial from 10a.m. -2 p.rn.•wear long-sleeve shorts , pants, hats and sunglasses children under 6 months of age: ask a doctor

Description

Zinc Oxide 20%                                   Sunscreen

Section 50566-9

• rash or initation develops and lasts

Section 50567-7

•keep out of eyes. Rinse with waterto remove.

Section 50570-1

• damaged or broken skin.

Section 51727-6

Benzyl Alcohol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Citric Acid, Coco-Caprylate, Dehydroacetic Acid, Glycerin, Glyceryl Stearate, Niacinamide, Panthenol, Polyhydroxystearic Acid, Saccharide Isomerate, Sodium Phytate, Sodium Stearoyl Glutamate, Sucrose Palmitate, Sucrose Tristearate, Tocopheryl Acetate, Xanthan Gum, Water.

Section 51945-4

image description

Section 55106-9

Zinc Oxide 20%                                   Sunscreen

Section 60561-8

Protect the product in this container from excessive heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

•helps prevent sunburn• If used as directed with other sun protection measures ( see Oirections ),decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

• apply liberally 15 minutes before sun exposure and as needed. Reapply: after 40 minutes of sweeming or sweating immidiately after towel drying at least every 2 hours.  Sun Protection Measure s. Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly usea sunscreen wrtha Broad Spectrum SPF value of15 or higher and other suncrin protection measures including: • limrt time in the sun, especial from 10a.m. -2 p.rn.•wear long-sleeve shorts , pants, hats and sunglasses children under 6 months of age: ask a doctor

Section 50566-9 (50566-9)

• rash or initation develops and lasts

Section 50567-7 (50567-7)

•keep out of eyes. Rinse with waterto remove.

Section 50570-1 (50570-1)

• damaged or broken skin.

Section 51727-6 (51727-6)

Benzyl Alcohol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Citric Acid, Coco-Caprylate, Dehydroacetic Acid, Glycerin, Glyceryl Stearate, Niacinamide, Panthenol, Polyhydroxystearic Acid, Saccharide Isomerate, Sodium Phytate, Sodium Stearoyl Glutamate, Sucrose Palmitate, Sucrose Tristearate, Tocopheryl Acetate, Xanthan Gum, Water.

Section 51945-4 (51945-4)

image description

Section 55106-9 (55106-9)

Zinc Oxide 20%                                   Sunscreen

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun


Raw Label Data

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