Active Ingredient(S)
Octocrylene 8.0% Ethylhexyl Salicylate 5.0% Ethylhexyl Methoxycinnamate 7.5 %
Fitish Spf 50 Face
FDA Label NDC 84417-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fitish Holdings, Llc for the product Fitish Spf 50 Face (NDC 84417-002). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Use
USES Helps prevent sunburn
Warnings
WARNINGS For external use only.
Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product, keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask doctorif 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 directly to clean skin 15 minutes before sun exposure and anywhere you want extra glow. Reapply after
40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Can be used
on body as well.
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 limiting time in the sun, especially from 10 a.m.-2 p.m. and wear long-sleeved
shirts, pants, hats and sunglasses
Other Information
No data available
Inactive Ingredients
Aloe Yohjyu Matsu Ekisu (Aloe Vera), C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Camellia Sinensis Leaf Oil, Caprylic/Capric Triglyceride, Cetyl Ethylhexanoate, Cocos Nucifera
(Coconut) Oil, Cocos Nucifera Extract, Cyclopentasiloxane, Dextrin Palmitate, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Dicaprylyl Carbonate, Ethyl Macadamiate, Ethylhexyl
Isopalmitate, Isononyl Isononanoate, Isopropyl Lauroyl Sarcosinate, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E)
Package Label - Principal Display Panel
Label (Label)
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