Protectint 22w Cream
FDA Label NDC 59735-913

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pml Nyc, Llc for the product Protectint 22w (NDC 59735-913). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Otc - Keep Out Of Reach Of Children

→ Warnings

→ Indications & Usage

→ Dosage & Administration

→ Inactive Ingredient

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredients:Zinc Oxide 13.58%, Homosalate 7.0%, Octisalate 5.0%

Otc - Purpose

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If product is swallowed, get medical help, or contact a poison control center right away.

Warnings

For External use only

Do not useon damaged or broken skin

When using this product,keep out of eyes. Rinse with water to remove

Indications & Usage

Stop use and ask a doctorif rash occurs

Dosage & Administration

Directions

Apply generously and evenly 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.- 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Inactive Ingredient

Inactive Ingredients:IAqua/Water/Eau, Isononyl Isononanoate, Butyloctyl Salicylate, Propanediol, Silica, Glycerin,1,2-Hexanediol, Lecithin, Coco-Caprylate/Caprate, Cetearyl Alcohol, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ectoin, Coco-Glucoside, Polyhydroxystearic acid, Citric Acid, Triethoxycaprylylsilane, Morinda Citrifolia Extract, Xanthan Gum, Sodium Phytate, Bentonite, Sodium Hyaluronate, Tocopherol