SPL v1
SPL
SPL Set ID 3cce91b1-311b-4c95-e063-6294a90a2d7a
Route
TOPICAL
Published
Effective Date 2025-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4 g) Zinc Oxide (0.001 g)
Inactive Ingredients
Ethylhexyl Palmitate Aloe Barbadensis Leaf Juice Isohexadecane 1,2-hexanediol Squalane Olea Europaea (olive) Fruit Oil Aqua Glycerin Cyclodextrin Alpha-tocopherol Acetate Carbomer Butylene Glycol Centella Asiatica Leaf Hydroxyacetophenone C12-20 Alkyl Glucoside Xanthan Gum C14-22 Alcohols Potassium Cetyl Phosphate Arginine Paeonia Lactiflora Root Ceramide Np

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-21
Description

Zinc Oxide 20% Titanium Dioxide 10%

Purpose

Sunscreen ​Sunscreen

Medication Information

Purpose

Sunscreen ​Sunscreen

Description

Zinc Oxide 20% Titanium Dioxide 10%

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

The Texture Is Fresh, Not Sticky, Light And Moist.



Effectively blocks ultraviolet rays, prevents sunburn, photoaging, and pigmentation, while also having auxiliary functions such as moisturizing and skin conditioning to help maintain the skin's hydrated state during sun protection. Suitable for daily or outdoor protection needs.



Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • 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:

​ 1. limit time in the sun, especially from 10 a.m. - 2 p.m.

2. Wear long-sleeved shirts, pants, hats, and sunglasses

  • Children under 6 months of age: Ask a doctor
Do Not Use
  • On damaged or broken skin
Purpose(s)
  • Sunscreen
  • ​Sunscreen
Other Information
  • Protect this product from excessive heat and direct sun
Active Ingredient(s)
  • Zinc Oxide 20%
  • Titanium Dioxide 10%
Inactive Ingredients

AQUA, ZINC OXIDE, TITANIUM DIOXIDE, GLYCERIN, ETHYLHEXYL PALMITATE, SQUALANE, ISOHEXADECANE, C14-22 ALCOHOLS, 1,2-HEXANEDIOL, POTASSIUM CETYL PHOSPHATE, HYDROXYACETOPHENONE, C12-20 ALKYL GLUCOSIDE, CARBOMER, ARGININE, XANTHAN GUM, BUTYLENE GLYCOL, ALPHA-TOCOPHEROL ACETATE, ALOE BARBADENSIS LEAF JUICE, CENTELLA ASIATICA LEAF, OLEA EUROPAEA (OLIVE) FRUIT OIL, PAEONIA LACTIFLORA ROOT, CERAMIDE NP, CYCLODEXTRIN

Questions Or Comments?

934-935-7135 / [email protected]

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.

Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a health professional before use.

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)

The Texture Is Fresh, Not Sticky, Light And Moist.



Effectively blocks ultraviolet rays, prevents sunburn, photoaging, and pigmentation, while also having auxiliary functions such as moisturizing and skin conditioning to help maintain the skin's hydrated state during sun protection. Suitable for daily or outdoor protection needs.



Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • 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:

​ 1. limit time in the sun, especially from 10 a.m. - 2 p.m.

2. 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
Purpose(s)
  • Sunscreen
  • ​Sunscreen
Other Information (Other information)
  • Protect this product from excessive heat and direct sun
Active Ingredient(s) (Active ingredient(s))
  • Zinc Oxide 20%
  • Titanium Dioxide 10%
Inactive Ingredients (Inactive ingredients)

AQUA, ZINC OXIDE, TITANIUM DIOXIDE, GLYCERIN, ETHYLHEXYL PALMITATE, SQUALANE, ISOHEXADECANE, C14-22 ALCOHOLS, 1,2-HEXANEDIOL, POTASSIUM CETYL PHOSPHATE, HYDROXYACETOPHENONE, C12-20 ALKYL GLUCOSIDE, CARBOMER, ARGININE, XANTHAN GUM, BUTYLENE GLYCOL, ALPHA-TOCOPHEROL ACETATE, ALOE BARBADENSIS LEAF JUICE, CENTELLA ASIATICA LEAF, OLEA EUROPAEA (OLIVE) FRUIT OIL, PAEONIA LACTIFLORA ROOT, CERAMIDE NP, CYCLODEXTRIN

Questions Or Comments? (Questions or comments?)

934-935-7135 / [email protected]

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.

Pregnancy Or Breast Feeding Section (Pregnancy or breast feeding section)

If pregnant or breast-feeding, ask a health professional before use.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:49.701841 · Updated: 2026-03-14T23:09:49.100948