83447-005

83447-005
SPL v4
SPL
SPL Set ID 1bc29960-5e73-e8ab-e063-6294a90a3f80
Route
CUTANEOUS
Published
Effective Date 2024-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (21.8 g)
Inactive Ingredients
Sorbitan Monostearate Polyglyceryl-4 Isostearate Hexyl Laurate Coconut Oil Jojoba Oil Centella Asiatica Triterpenoids Ceramide 9 Tocopherol Lemon Hyaluronate Sodium Potassium Sorbate Aloe Vera Leaf Water Cetyl Dimethicone 45 Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-26

Description

Zinc Oxide 21.8%


Medication Information

Description

Zinc Oxide 21.8%

Uses

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 50565-1

Keep out of reach of children.

If swallowed, get medical help or

contact Poison Control Center

right away.



Section 50570-1

Do not use on damaged or broken skin.



Section 51945-4

Section 55105-1

sunscreen

Section 55106-9



Zinc Oxide 21.8%

Warnings

Warnings

For external use only

Do not use on damaged or broken skin.

When using the 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 Poison Control Center right away.

Directions

Directions Apply liberally 15 minutes before sun exposure Reapply: After 40 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 value of 15 or higher and other sun protection measures including: Limit time in the sun,

especially from 10a.m. - 2p.m.

■Wear long-sleeve shirts, pants, hats, and sunglasses.

■Children under 6 months: Ask a doctor.



Other Information

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


Structured Label Content

Uses

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 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or

contact Poison Control Center

right away.



Section 50570-1 (50570-1)

Do not use on damaged or broken skin.



Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

sunscreen

Section 55106-9 (55106-9)



Zinc Oxide 21.8%

Warnings

Warnings

For external use only

Do not use on damaged or broken skin.

When using the 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 Poison Control Center right away.

Directions

Directions Apply liberally 15 minutes before sun exposure Reapply: After 40 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 value of 15 or higher and other sun protection measures including: Limit time in the sun,

especially from 10a.m. - 2p.m.

■Wear long-sleeve shirts, pants, hats, and sunglasses.

■Children under 6 months: Ask a doctor.



Other Information (Other information)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)