Proven Personalized Day Moisturizer With Spf 50 Cream
FDA Label NDC 73572-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proven Skincare for the product Proven Personalized Day Moisturizer With Spf 50 (NDC 73572-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Zinc Oxide 15%

Purpose

Sunscreen

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

Do Not Use

  • on damaged or broken skin

Stop Use And Ask A Doctor

  • if rash occurs

When Using This Product

  • keep out of eyes. Rinse with water to remove.

Keep Out Of Reach Of Children.

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

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.

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.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.

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

Other Information

• protect this product from excessive heat and direct sun.

Questions Or Comments?

Call (650) 427-0836

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