SPL v6
SPL
SPL Set ID 2cdbeb73-b805-f144-e063-6294a90a088d
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (75.5 mg) Titanium Dioxide (20 mg)
Inactive Ingredients
Fd&c Yellow No. 5 Aluminum Lake Ferric Oxide Red D&c Red No. 6 Barium Lake Propylene Carbonate D&c Red No. 28 Polyethylene Stearalkonium Hectorite Silicon Dioxide Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Microcrystalline Wax Polybutene (1400 Mw) Caprylic/capric Triglyceride Mica Dicalcium Phosphate D&c Red No. 7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-02
Description

Zinc Oxide 7.55% Titanium Dioxide 2%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 7.55% Titanium Dioxide 2%

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 51945-4

Warnings

For external use only.

Directions
  • For sunscreen use:
  • Apply liberally 15 minutes before sun exposure.
  • Use water-resistant sunscreen if swimming or sweating.
  • Reapply 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 15 or higher and other sun protection measure, including:
  • limit time in the sun, especially from 10 a.m - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglassess.
  • children under 6 months: Ask a doctor.
Do Not Use

on damaged skin

Other Information
  • Protect this product from excessive heat and direct sun.
Active Ingredients

Zinc Oxide 7.55%

Titanium Dioxide 2%

Inactive Ingredients

You Make Me Blush-

Polybutene, Caprylic/Capric Triglyceride, Polyethylene, Cera Microcristallina/Microcrystalline Wax/Cire Microcrystalline, Mica, Stearalkonium Hectorite, Silica, Propylene Carbonate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Dicalcium Phosphate, [May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410), Iron Oxides (CI 77491, CI 77492, CI 77499), Red 7 Lake (CI 15850)].

Orange You A Cutie-

Polybutene, Caprylic/Capric Triglyceride, Polyethylene, Cera Microcristallina/Microcrystalline Wax/Cire Microcrystalline, Mica, Stearalkonium Hectorite, Silica, Dicalcium Phosphate, Propylene Carbonate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate,

[May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Red 6 Lake (CI 15850), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410)].

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 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 cancer and early skin aging caused by the sun

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only.

Directions
  • For sunscreen use:
  • Apply liberally 15 minutes before sun exposure.
  • Use water-resistant sunscreen if swimming or sweating.
  • Reapply 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 15 or higher and other sun protection measure, including:
  • limit time in the sun, especially from 10 a.m - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglassess.
  • children under 6 months: Ask a doctor.
Do Not Use (Do not use)

on damaged skin

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Active Ingredients

Zinc Oxide 7.55%

Titanium Dioxide 2%

Inactive Ingredients (Inactive ingredients)

You Make Me Blush-

Polybutene, Caprylic/Capric Triglyceride, Polyethylene, Cera Microcristallina/Microcrystalline Wax/Cire Microcrystalline, Mica, Stearalkonium Hectorite, Silica, Propylene Carbonate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Dicalcium Phosphate, [May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410), Iron Oxides (CI 77491, CI 77492, CI 77499), Red 7 Lake (CI 15850)].

Orange You A Cutie-

Polybutene, Caprylic/Capric Triglyceride, Polyethylene, Cera Microcristallina/Microcrystalline Wax/Cire Microcrystalline, Mica, Stearalkonium Hectorite, Silica, Dicalcium Phosphate, Propylene Carbonate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate,

[May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Red 6 Lake (CI 15850), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410)].

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 (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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:45.125631 · Updated: 2026-03-14T23:11:30.674942