SPL v1
SPL
SPL Set ID 1a1bf910-f1bc-bd75-e063-6294a90a663f
Route
TOPICAL
Published
Effective Date 2024-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22.1 g)
Inactive Ingredients
Levomenol Caprylhydroxamic Acid Ethyl Ferulate Jojoba Oil Rice Bran Niacinamide Tetrahexyldecyl Ascorbate Glyceryl Caprylate Glycerin Boron Nitride Squalane Triethoxycaprylylsilane Mica Lauroyl Lysine Ferric Oxide Yellow Silicon Dioxide Ferrosoferric Oxide Ferric Oxide Red Hyaluronate Sodium Sclerocarya Birrea Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-04

Description

Zinc Oxide 22.1%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 22.1%

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cance and early skin aging caused by the sun.
Label

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 Proection Measures: Spending time in the sun increases yur 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 10am-2pm; 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.

Active Ingredient

Zinc Oxide 22.1%

Other Information

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

Inactive Ingredients

Sodium hyaluronate

Niacinimide

Mica

Lauroyl lysine

Boron nitride

Silica

Triethoxycaprylylsilane

Ethyl ferulate

Oryza sativa (rice) bran extract

Iron oxides

Bisabolol

Squalane

Simmondsia chinensis (jojoba) seed oil

Tetrahexyldecyl ascorbate

Sclerocarya birrea seed oil

Glyceryl caprylate

Glycerin

Caprylhydroxamic acid

When Using Thi Sproduct

When using this product keeo 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

If product is 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 cance and early skin aging caused by the sun.
Label (label)

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 Proection Measures: Spending time in the sun increases yur 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 10am-2pm; Wear long-sleeved shirts, pants, hats and sunglasses; Children under 6 months of age: ask a doctor.
Do Not Use (Do not use)

Do not use on damaged or broken skin.

Active Ingredient (Active ingredient)

Zinc Oxide 22.1%

Other Information

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

Inactive Ingredients

Sodium hyaluronate

Niacinimide

Mica

Lauroyl lysine

Boron nitride

Silica

Triethoxycaprylylsilane

Ethyl ferulate

Oryza sativa (rice) bran extract

Iron oxides

Bisabolol

Squalane

Simmondsia chinensis (jojoba) seed oil

Tetrahexyldecyl ascorbate

Sclerocarya birrea seed oil

Glyceryl caprylate

Glycerin

Caprylhydroxamic acid

When Using Thi Sproduct (When using thi sproduct)

When using this product keeo out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (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 product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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