Proven Personalized Day Moisturizer With Spf 50

Proven Personalized Day Moisturizer With Spf 50
SPL v2
SPL
SPL Set ID ba9b3cdc-c237-7ce2-e053-2995a90ac175
Route
TOPICAL
Published
Effective Date 2021-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (150 mg)
Inactive Ingredients
Allantoin Levomenol Butyloctyl Salicylate Alkyl (c12-15) Benzoate Caprylyl Glycol Cetyl Alcohol Dimethiconol/propylsilsesquioxane/silicate Crosspolymer (450000000 Mw) Edetate Disodium Anhydrous Ethylhexyl Isononanoate Ethylhexylglycerin Glycerin Glyceryl Monostearate Hexylene Glycol Lysophosphatidylcholine, Soybean Octyldodecyl Neopentanoate Peg-75 Stearate Phenoxyethanol Pullulan Apple Betasizofiran Silicon Dioxide Squalane Trilaureth-4 Phosphate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-14
Description

Zinc Oxide 15%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 15%

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.

Warnings

For external use only

Directions

• apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours •reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor • Use water resistant sunscreen if swimming or sweating.

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. Sun Protection Measures:

Do Not Use
  • on damaged or broken skin
Other Information

• protect this product from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Zinc Oxide 15%

Inactive Ingredients

Allantoin, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Alcohol, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Disodium EDTA, Ethylhexyl Isononanoate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Lysolecithin, Octyldodecyl Neopentanoate, PEG-75 Stearate, Phenoxyethanol, Pullulan, Pyrus Malus (Apple) Fruit Extract, Sclerotium Gum, Silica, Squalane, Trilaureth-4 Phosphate, Water, Xanthan Gum

Questions Or Comments?

Call (650) 427-0836

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.

Purpose

Sunscreen

Warnings

For external use only

Directions

• apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours •reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor • Use water resistant sunscreen if swimming or sweating.

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. Sun Protection Measures:

Do Not Use (Do not use)
  • on damaged or broken skin
Other Information

• protect this product from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Zinc Oxide 15%

Inactive Ingredients

Allantoin, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Alcohol, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Disodium EDTA, Ethylhexyl Isononanoate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Lysolecithin, Octyldodecyl Neopentanoate, PEG-75 Stearate, Phenoxyethanol, Pullulan, Pyrus Malus (Apple) Fruit Extract, Sclerotium Gum, Silica, Squalane, Trilaureth-4 Phosphate, Water, Xanthan Gum

Questions Or Comments? (Questions or comments?)

Call (650) 427-0836

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 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: 2026-02-15T12:02:19.038279 · Updated: 2026-03-14T23:01:48.065872