Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 8b298516-70df-47ab-834f-51dcde28a43a
Route
TOPICAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ci 77891 (55 mg) Zinc Cation (100 mg)
Inactive Ingredients
Water C12-15 Alkyl Benzoate Isohexadecane Isononyl Isononanoate Dicaprylyl Ether Peg-30 Dipolyhydroxystearate Triethylhexanoin Polyglyceryl-4 Isostearate Dicaprylyl Carbonate Behenyl Acrylate Polymer Stearic Acid Ceramide Np Ceramide Ap Carbomer Niacinamide Soybean Oil Cetearyl Alcohol Triethoxycaprylylsilane Behentrimonium Methosulfate Triethyl Citrate Sodium Chloride Sodium Hyaluronate Sodium Lauroyl Lactylate Cholesterol Aluminum Stearate Alumina Aluminum Hydroxide Phenoxyethanol P-anisic Acid Chlorphenesin Tocopherol Disodium Stearoyl Glutamate Propylene Carbonate Citric Acid Caprylyl Glycol Capryloyl Salicylic Acid Caprylic/capric Triglyceride Trisodium Ethylenediamine Disuccinate Diethylhexyl Syringylidenemalonate Disteardimonium Hectorite Xanthan Gum Phytosphingosine Polyhydroxystearic Acid (2300 Mw) Benzoic Acid Ci 77492 Ci 77491 Ci 77499

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-15

Description

Titanium dioxide 5.5% Zinc oxide 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 5.5% Zinc oxide 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

Warnings

For external use only

Directions

For sunscreen 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 boken skin

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

Titanium dioxide 5.5%

Zinc oxide 10%

Inactive Ingredients

water, C12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, polyglyceryl-3 diisostearate, ceramide NP, ceramide AP, ceramide EOP, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, alkyl sodium chloride, glycine soja (soybean) oil, cetearyl alcohol, triethylhexanoin, behentrimonium methosulfate, lauryl laurate, cholesterol, aluminum stearate, chlorphenesin, tocopherol, disodium EDTA, iron oxides, p-anisic acid, alumina, aluminum hydroxide, phenoxyethanol, salicylic acid, capryloyl salicylic acid, trisodium ethylenediamine disuccinate, propylene carbonate, citric acid, castoryl dimethyl caprate, distearyldimonium chloride, glyceryl trilinoleate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, 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

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
  • 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 boken skin

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

Titanium dioxide 5.5%

Zinc oxide 10%

Inactive Ingredients (Inactive ingredients)

water, C12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, polyglyceryl-3 diisostearate, ceramide NP, ceramide AP, ceramide EOP, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, alkyl sodium chloride, glycine soja (soybean) oil, cetearyl alcohol, triethylhexanoin, behentrimonium methosulfate, lauryl laurate, cholesterol, aluminum stearate, chlorphenesin, tocopherol, disodium EDTA, iron oxides, p-anisic acid, alumina, aluminum hydroxide, phenoxyethanol, salicylic acid, capryloyl salicylic acid, trisodium ethylenediamine disuccinate, propylene carbonate, citric acid, castoryl dimethyl caprate, distearyldimonium chloride, glyceryl trilinoleate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, 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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