Otc - Active Ingredient
OCTINOXATE 7.5%
OCTISALATE 3.0%
ZINC OXIDE 8.0%
Sun-kissed Suncream
FDA Label NDC 78493-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lee & Gen Global Corporation for the product Sun-kissed Suncream (NDC 78493-001). 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, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
Dosage & Administration
For sunscreen use:
■ apply liberally 15 minutes before sun exposure
■ reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.
■ 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 of age: ask a doctor
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 using and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.
Inactive Ingredient
Water, Cyclopentasiloxane, Ethylhexyl Isononanoate, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Phenoxyethanol, Sodium Chloride, Triethoxycaprylylsilane, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Iodopropynyl Butylcarbamate, Ascorbyl Palmitate, BHT, Retinyl Palmitate, Dipropylene Glycol, Zea Mays (Corn) Oil, Tocopherol
Other Safety Information
Protect the product in this container from excessive heat and direct sunlight
* Please review the disclaimer below.
