Otc - Active Ingredient
Active Ingredients Purpose
Titanium Dioxide 3.2% Sunscreen
Zinc Oxide 10.3% Sunscreen
The following Structured Product Label (SPL) was submitted to the FDA by 323 Innovations for the product Kashmere Anti-aging Sunscreen Moisturizer Broad Spectrum Spf 30 (NDC 72334-101). 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, indications & usage, warnings, 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.
Active Ingredients Purpose
Titanium Dioxide 3.2% Sunscreen
Zinc Oxide 10.3% 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
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Directions
· Apply generously 15 minutes before sun exposure
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· Children under 6 months: Ask a doctor
· 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
Inactive Ingredients
Water (Aqua), Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Dipotassium Glycyrrhizate, Alumina, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/PEG-10/15 Crosspolymer, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Phenoxyethanol
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