mineral sunscreen broad spectrum spf30

mineral sunscreen broad spectrum spf30
SPL v4
SPL
SPL Set ID f65441f7-d9a1-2129-e053-2995a90a3f9b
Route
topical
Published
Effective Date 2023-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (34.4 mg) zinc cation (48.8 mg)
Inactive Ingredients
levomenol caffeine triethoxycaprylylsilane aluminum oxide smallanthus sonchifolius root juice maltodextrin hyaluronate sodium phenoxyethanol water dimethicone alkyl (c12-15) benzoate propanediol butyloctyl salicylate argan oil .alpha.-tocopherol acetate sodium chloride disteardimonium hectorite niacinamide polyglyceryl-4 isostearate hexyl laurate olive oil polyglyceryl-6 esters dimethicone/vinyl dimethicone crosspolymer (soft particle) 1,2-hexanediol caprylyl glycol hydroxyacetophenone magnesium sulfate, unspecified form avocado oil polyglyceryl-10 pentaoleate shea butter stearic acid .alpha.-glucan oligosaccharide silicon dioxide grape seed oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-03-01
Purpose

Sunscreen

Description

TITANIUM DIOXIDE 3.44% ZINC OXIDE 4.88%

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
  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Immediately after towel drying 
  • At least every 2 hours
  • Children under 6 months of age: Ask a doctor 
  • Sun Protection Measures. Spending time in the sun increases your risk of a 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.
Other Information
  • Protect the product in this container from excessive heat and direct sun
Inactive Ingredients

WATER (AQUA), DIMETHICONE, C12-15 ALKYL BENZOATE, PROPANEDIOL, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLOCTYL SALICYLATE, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, NIACINAMDE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, OLIVE OIL POLYGLYCERYL-6 ESTERS, POLYSILICONE-11, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, PERSEA GRATISSIMA (AVOCADO) OIL, POLYGLYCERYL-6 PENAOLEATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, STEARIC ACID, ALPHA-GLUCAN OLIGOSACCHARIDE, SILICA, VITIS VINIFERA (GRAPE) SEED OIL, BISABOLOL, CAFFEINE, TRIETHOXYCAPRYLYLSILANE, ALUMINA, POLYMNIA SONCHIFOLIA ROOT JUICE, POLYHYDROXYSTEARIC ACID, MALTODEXTRIN, SODIUM HYALURONATE, PHENOXYETHANOL, LACTOBACILLUS, MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

Description

TITANIUM DIOXIDE 3.44% ZINC OXIDE 4.88%

Do Not Use

on damaged or broken skin

Drug Facts

Package Labeling:

Active Ingredients

TITANIUM DIOXIDE 3.44%

ZINC OXIDE 4.88%

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor 

If swallowed. get medical help or contact a Poison Control Center right away.

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 (PURPOSE)

Sunscreen

Directions
  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Immediately after towel drying 
  • At least every 2 hours
  • Children under 6 months of age: Ask a doctor 
  • Sun Protection Measures. Spending time in the sun increases your risk of a 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.
Other Information
  • Protect the product in this container from excessive heat and direct sun
Inactive Ingredients

WATER (AQUA), DIMETHICONE, C12-15 ALKYL BENZOATE, PROPANEDIOL, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLOCTYL SALICYLATE, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, NIACINAMDE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, OLIVE OIL POLYGLYCERYL-6 ESTERS, POLYSILICONE-11, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, PERSEA GRATISSIMA (AVOCADO) OIL, POLYGLYCERYL-6 PENAOLEATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, STEARIC ACID, ALPHA-GLUCAN OLIGOSACCHARIDE, SILICA, VITIS VINIFERA (GRAPE) SEED OIL, BISABOLOL, CAFFEINE, TRIETHOXYCAPRYLYLSILANE, ALUMINA, POLYMNIA SONCHIFOLIA ROOT JUICE, POLYHYDROXYSTEARIC ACID, MALTODEXTRIN, SODIUM HYALURONATE, PHENOXYETHANOL, LACTOBACILLUS, MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Package Labeling:

Active Ingredients

TITANIUM DIOXIDE 3.44%

ZINC OXIDE 4.88%

When Using This Product (when using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor  (Stop use and ask a doctor )

If swallowed. get medical help or contact a Poison Control Center right away.

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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.936573 · Updated: 2026-03-14T23:02:08.105317