Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 8e94e203-d3cf-45a1-88f9-6999f0aab22b
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (60 mg) Zinc Cation (50 mg)
Inactive Ingredients
Water Glycerin Alkyl (c12-15) Benzoate Dimethicone Isododecane Glyceryl Monostearate Butyloctyl Salicylate Propanediol Stearic Acid Peg-100 Stearate Sorbitan Monostearate Niacinamide Peg-8 Laurate Ceramide Np Ceramide Ap Ceramide 1 Sorbitan Isostearate Carboxypolymethylene Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Triethoxycaprylylsilane Sodium Citrate Sodium Lauroyl Lactylate Sodium Dodecylbenzenesulfonate Myristic Acid Hyaluronate Sodium Cholesterol Aluminum Hydroxide Palmitic Acid Phenoxyethanol Chlorphenesin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Caprylyl Glycol Citric Acid Acetate Panthenol Xanthan Gum Phytosphingosine Polyhydroxystearic Acid Stearate Polysorbate 60 Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-01
Description

Titanium dioxide 6% Zinc oxide 5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 6% Zinc oxide 5%

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.-2p.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 6%

Zinc oxide 5%

Inactive Ingredients

water, glycerin, C12-15 alkyl benzoate, dimethicone, glyceryl stearate, isododecane, butyloctyl salicylate, styrene/acrylates copolymer, propanediol, stearic acid, PEG-100 sterate, sorbitan stearate, niacinamide, acrylates/dimethicone copolymer, PEG-8 laurate, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, cetearyl alcohol, ceteareth-20, triethoxycaprylylsilane, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, aluminum hydroxide, palmitic acid, phenoxyethanol, chlorphenesin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, panthenol, xanthan gum, phytosphingosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin

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.-2p.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 6%

Zinc oxide 5%

Inactive Ingredients (Inactive ingredients)

water, glycerin, C12-15 alkyl benzoate, dimethicone, glyceryl stearate, isododecane, butyloctyl salicylate, styrene/acrylates copolymer, propanediol, stearic acid, PEG-100 sterate, sorbitan stearate, niacinamide, acrylates/dimethicone copolymer, PEG-8 laurate, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, cetearyl alcohol, ceteareth-20, triethoxycaprylylsilane, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, aluminum hydroxide, palmitic acid, phenoxyethanol, chlorphenesin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, panthenol, xanthan gum, phytosphingosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin

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: 2026-02-15T12:02:38.036267 · Updated: 2026-03-14T23:02:18.218337