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
Purpose

Sunscreen

Description

Titanium dioxide 6% Zinc oxide 5%

Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

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

Description

Titanium dioxide 6% Zinc oxide 5%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Titanium dioxide 6%

Zinc oxide 5%

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

Warnings

For external use only

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
Purpose

Sunscreen

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

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Titanium dioxide 6%

Zinc oxide 5%

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