Active Ingredient
Zinc oxide 9%
Titanium Dioxide 4.51%
Spf 30 Sunscreen Lotion
FDA Label NDC 83294-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cleure for the product Spf 30 Sunscreen (NDC 83294-101). 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 active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
• helps prevent sunburn • If used as directed
with other sun protection measutes 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 • When using this product keep out of eyes. Rinse with water to remove. • Stop use and ask doctor if rash occurs.
Otc - 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.
Directions
Apply liberally 15 minutes before
sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying• at least every 2 hours • Children under 6 months of age: 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 a Broad Spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2pm • wear long-sleeved shirts, pants, hats and sunglasses.
Inactive Ingredients
Water, Caprylic / Capric Triglyceride, Cetearyl Alcohol, STEARETH-2, Glycerin, STEARETH-21, Aloe Vera, Dimethicone, Phenoxyethanol, Sodium Stearoyl Glutamate, Xanthan Gum, Disodium EDTA, Ethylhexylglycerin
Storage And Handling
protect the product in this container from excessive heat and direct sun.
* Please review the disclaimer below.
