Active Ingredients
Avobenzone 2%,
Octinoxate 5%
Phelityl Day Spf 15 Cream
FDA Label NDC 59735-475
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 Phelityl Day Spf 15 (NDC 59735-475). 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, directions, inactive ingredients, other information, product label, 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 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.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash occurs.
- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away.
Directions
- Apply liberally 15 minutes before sun exposure
- reapply: after 40 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 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
- children under 6 months: Ask a doctor
Inactive Ingredients
Water, Glyceryl Stearate, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Silica, Butyrospermum Parkii (Shea) Butter, Emu Oil, Glycerin, PEG-100 Stearate, Polyglyceryl-3 Laurate, Taraktogenos Kurzii Seed Oil, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Allantoin, Carbomer, Ceteth-20, Disodium EDTA, Ethylhexylglycerin, O-Cymen-5-Ol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Fragrance, Steareth-2, Steareth-20, Triethanolamine, Phenoxyethanol.
Other Information
- protect this product from excessive heat and direct sun
* Please review the disclaimer below.
