Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID dafc8e62-7c99-1f6d-e053-2995a90a7791
Route
TOPICAL
Published
Effective Date 2022-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (21 g)
Inactive Ingredients
Coco Glucoside Sheanut Aloe Vera Leaf Coco-caprylate/caprate Caprylyl/capryl Oligoglucoside Sodium Ascorbyl Phosphate Betasizofiran Xanthan Gum Hydrolyzed Jojoba Esters (acid Form) Cucumber Polyhydroxystearic Acid (2300 Mw) Lecithin, Soybean Isostearic Acid Cetostearyl Alcohol Glycerin Phytate Sodium .alpha.-tocopherol Acetate Phenoxyethanol Sodium Benzoate Ethylhexylglycerin Cetearyl Glucoside Coconut Alkanes Polyglyceryl-3 Pentaricinoleate Squalane Water Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-24

Description

Active Ingredients Zinc Oxide (non-nano) 21 %


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

Shake well before use

Apply generously 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending lime in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with abroad Spectrum SPF value of 15 or higher and other sun protet-Wn measures including

Limit time in the sun, especial& from 10 arn.-2 p.m

Wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age Ask a doctor.

Description

Active Ingredients Zinc Oxide (non-nano) 21 %

Section 50565-1

Keep out of reach of children If swadlowed 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 eye Rinse with water to remove

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Inactive Ingredients

Water (Aqua)

Caprylic/Capric Triglyceride

Coconut Alkanes

Cetearyl Alcohol

Glycerin

Coco-Glucoside

Squalane

Butyrospermum Parkii Nut Extract

Aloe Barbadensis Leaf Juice

Cetearyl Glucoside

Coco-Caprylate/Caprate

Caprylyl/Capryl Glucoside

Hydrolyzed Jojoba Esters

Cucumis Sativus (Cucumber) Fruit Extract

sr-Hydrozoan Polypeptide-1

Polyhydroxystearic Acid

Polyglyceryl-3 Polyricinoleate

Isostearic Acid

Lecithin

SodiuM Ascorbyl Phosphate

Sclerotium Gum

Xanthan Gum

Ethylhexylglycerin

Sodium Phytate

Tocopheryl Acetate

Phenoxyethanol

Sodium Benzoate

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Zinc Oxide (non-nano) 21 %

Section 60561-8

Other information

'

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

May stain some fabrics


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

Shake well before use

Apply generously 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending lime in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with abroad Spectrum SPF value of 15 or higher and other sun protet-Wn measures including

Limit time in the sun, especial& from 10 arn.-2 p.m

Wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age Ask a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children If swadlowed 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 eye 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)

Caprylic/Capric Triglyceride

Coconut Alkanes

Cetearyl Alcohol

Glycerin

Coco-Glucoside

Squalane

Butyrospermum Parkii Nut Extract

Aloe Barbadensis Leaf Juice

Cetearyl Glucoside

Coco-Caprylate/Caprate

Caprylyl/Capryl Glucoside

Hydrolyzed Jojoba Esters

Cucumis Sativus (Cucumber) Fruit Extract

sr-Hydrozoan Polypeptide-1

Polyhydroxystearic Acid

Polyglyceryl-3 Polyricinoleate

Isostearic Acid

Lecithin

SodiuM Ascorbyl Phosphate

Sclerotium Gum

Xanthan Gum

Ethylhexylglycerin

Sodium Phytate

Tocopheryl Acetate

Phenoxyethanol

Sodium Benzoate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Zinc Oxide (non-nano) 21 %

Section 60561-8 (60561-8)

Other information

'

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

May stain some fabrics


Advanced Ingredient Data


Raw Label Data

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