Proven Personalized Day Moisturizer Sunscreen Spf 30

Proven Personalized Day Moisturizer Sunscreen Spf 30
SPL v3
SPL
SPL Set ID 5275d2c5-96e8-424d-a3c8-feea778191e4
Route
TOPICAL
Published
Effective Date 2025-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (175 mg)
Inactive Ingredients
Water Ethylhexyl Olivate Medium-chain Triglycerides Butyloctyl Salicylate C13-15 Alkane Propanediol Isostearic Acid Dicaprylyl Ether Disteardimonium Hectorite Argania Spinosa Kernel Oil .alpha.-tocopherol Acetate Hydroxyacetophenone Sodium Chloride Caprylyl Glycol Pentylene Glycol Squalane 1,2-hexanediol Tetrasodium Glutamate Diacetate Bisabolol Ethylhexylglycerin Limonene, (+)- Linalool, (+/-)- Sodium Hydroxide Citral Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Zinc Oxide 17.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 17.5%

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 sun.
Warnings
  • For external use only
Directions
  • apply liberally 15 minutes before sun exposure
  • Reapply: • Use a water-resistant sunscreen if swimming or sweating 
  • at least every 2 hours.
  • Sun Protection MeasuresSpending 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 your time in the sun, especially from10 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 broken skin
Drug Facts

Active Ingredient

Zinc Oxide 17.5%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Inactive Ingredients

Water, Ethylhexyl Olivate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, Butyloctyl Salicylate, C13-15 Alkane, Propanediol, Isostearic Acid, Lecithin, Polyhydroxystearic Acid, Dicaprylyl Ether, Disteardimonium Hectorite, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Hydroxyacetophenone, Sodium Chloride, Caprylyl Glycol, Pentylene Glycol, Squalane, 1,2-Hexanediol, Fragrance, Tetrasodium Glutamate Diacetate, Bisabolol, Ethylhexylglycerin, Limonene, Linalool, Sodium Hydroxide, Citral, Tocopherol

Questions Or Comments?

go to www.provenskincare.com

When Using This Product
  • keep out of eyes. Rinse with water to remove
Stop Use and Ask A Doctor

if skin 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 sun.
Purpose

Sunscreen

Warnings
  • For external use only
Directions
  • apply liberally 15 minutes before sun exposure
  • Reapply: • Use a water-resistant sunscreen if swimming or sweating 
  • at least every 2 hours.
  • Sun Protection MeasuresSpending 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 your time in the sun, especially from10 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 broken skin
Drug Facts

Active Ingredient (Active ingredient)

Zinc Oxide 17.5%

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Inactive Ingredients (Inactive ingredients)

Water, Ethylhexyl Olivate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, Butyloctyl Salicylate, C13-15 Alkane, Propanediol, Isostearic Acid, Lecithin, Polyhydroxystearic Acid, Dicaprylyl Ether, Disteardimonium Hectorite, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Hydroxyacetophenone, Sodium Chloride, Caprylyl Glycol, Pentylene Glycol, Squalane, 1,2-Hexanediol, Fragrance, Tetrasodium Glutamate Diacetate, Bisabolol, Ethylhexylglycerin, Limonene, Linalool, Sodium Hydroxide, Citral, Tocopherol

Questions Or Comments? (Questions or Comments?)

go to www.provenskincare.com

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 skin 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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