Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 372894af-bed7-474f-95d4-69a8c3f215ef
Route
TOPICAL
Published
Effective Date 2025-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ci 77891 (26.6 mg) Zinc Cation (153.5 mg)
Inactive Ingredients
Water C15-19 Alkane Glycerin Dicaprylyl Carbonate Niacinamide Propanediol Cetearyl Isononanoate Polyhydroxystearic Acid (2300 Mw) Dimethicone Ethylhexyl Methoxycrylene Powdered Cellulose Triethylhexanoin Isohexadecane Triethoxycaprylylsilane Steareth-20 Silica Steareth-2 Ceramide Np Ceramide Ap Ceramide 1 Carbomer Glyceryl Stearate Cetearyl Alcohol Behentrimonium Methosulfate Triethyl Citrate Sodium Lauroyl Lactylate Cholesterol Aluminum Stearate Alumina Chlorphenesin Tocopherol Hydroxyacetophenone Caprylyl Glycol Caprylic/capric Triglyceride Citric Acid Diethylhexyl Syringylidenemalonate Panthenol Xanthan Gum Phytosphingosine Polysorbate 20 Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

Titanium dioxide 2.66% Zinc oxide 15.35%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 2.66% Zinc oxide 15.35%

Use
  • 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:

  • shake well before use
  • 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:
  •    limit time in the sun, especially from 10 a.m. - 2 p.m.
  •    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.

Other Information
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Titanium dioxide 2.66%

Zinc oxide 15.35%

Inactive Ingredients

water, C15-19 allkane, glycerin, dicaprylyl carbonate, niacinamide, propanediol, cetearyl isononanoate, polyhydroxystearic acid, dimethicone, ethylhexyl methoxycrylene, cellulose, triethylhexanoin, isohexadecane, triethoxycaprylylsilane, steareth-20, silica, steareth-2, ceramide NP, ceramide AP, ceramide EOP, carbomer, glyceryl stearate, cetearyl alcohol, behentrimonium methosulfate, triethyl citrate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, chlorphenesin, tocopherol, hydroxyacetophenone, caprylyl glycol, caprylic/capric triglyceride, citric acid, diethylhexyl syringylidenemalonate, panthenol, xanthan gum, phytosphingosine, polysorbate 20, acrylates/C10-30 alkyl acrylate crosspolymer, benzoic acid

Questions Or Comments?

Toll-free number 1-888-768-2915

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

Use
  • 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:

  • shake well before use
  • 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:
  •    limit time in the sun, especially from 10 a.m. - 2 p.m.
  •    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.

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Active Ingredients (Active ingredients)

Titanium dioxide 2.66%

Zinc oxide 15.35%

Inactive Ingredients (Inactive ingredients)

water, C15-19 allkane, glycerin, dicaprylyl carbonate, niacinamide, propanediol, cetearyl isononanoate, polyhydroxystearic acid, dimethicone, ethylhexyl methoxycrylene, cellulose, triethylhexanoin, isohexadecane, triethoxycaprylylsilane, steareth-20, silica, steareth-2, ceramide NP, ceramide AP, ceramide EOP, carbomer, glyceryl stearate, cetearyl alcohol, behentrimonium methosulfate, triethyl citrate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, chlorphenesin, tocopherol, hydroxyacetophenone, caprylyl glycol, caprylic/capric triglyceride, citric acid, diethylhexyl syringylidenemalonate, panthenol, xanthan gum, phytosphingosine, polysorbate 20, acrylates/C10-30 alkyl acrylate crosspolymer, benzoic acid

Questions Or Comments? (Questions or comments?)

Toll-free number 1-888-768-2915

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

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