SPL v2
SPL
SPL Set ID 3fa58ac5-f45c-369a-e063-6294a90a46e4
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (73.5 mg)
Inactive Ingredients
Silicon Dioxide Triethoxycaprylylsilane Bambusa Arundinacea Stem Dimethicone/peg-10/15 Crosspolymer Sodium Citrate Modified Corn Starch (1-octenyl Succinic Anhydride) Dipropylene Glycol Water Ci 77491 Ci 77499 Isododecane Chlorphenesin Glycyrrhiza Glabra (licorice) Root Niacinamide Dimethicone Crosspolymer Stearalkonium Bentonite Sodium Chloride Triethyl Citrate Caprylyl Glycol Ci 77891 1,2-hexanediol Dimethicone Tocopherol Ci 77492 Glycerin Butylene Glycol Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01
Description

Zinc oxide 7.35%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc oxide 7.35%

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.
Image

Warnings

For external use only

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • 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 witha Broad Spectrum SPF value of 15 or higher and other sun protection measures including • Limit time in the sun, especially from 10 a.m.-2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
Do Not Use

on damaged or broken skin

Active Ingredient

Zinc oxide 7.35%

Other Information

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

Inactive Ingredients

Dimethicone, Isododecane, Corn Starch Modified, Aqua/Water/Eau, Butylene Glycol, Glycerin, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Niacinamide, Stearalkonium Bentonite, Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Sodium Chloride, Triethyl Citrate, Bambusa Arundinacea Stem Powder, Triethoxycaprylylsilane, 1,2-Hexanediol, Caprylyl Glycol, Chlorphenesin, Dipropylene Glycol, Sodium Citrate, Tocopherol, Glycyrrhiza Glabra (Licorice) Root Extract, [May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)]

Questions Or Comments?

Call 1-800-426-8374

When Using This 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 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 cancer and early skin aging caused by the sun.
Image (image)

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • 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 witha Broad Spectrum SPF value of 15 or higher and other sun protection measures including • Limit time in the sun, especially from 10 a.m.-2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Zinc oxide 7.35%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Dimethicone, Isododecane, Corn Starch Modified, Aqua/Water/Eau, Butylene Glycol, Glycerin, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Niacinamide, Stearalkonium Bentonite, Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Sodium Chloride, Triethyl Citrate, Bambusa Arundinacea Stem Powder, Triethoxycaprylylsilane, 1,2-Hexanediol, Caprylyl Glycol, Chlorphenesin, Dipropylene Glycol, Sodium Citrate, Tocopherol, Glycyrrhiza Glabra (Licorice) Root Extract, [May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)]

Questions Or Comments? (Questions or comments?)

Call 1-800-426-8374

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:45.765427 · Updated: 2026-03-14T23:11:32.027299