Active Ingredients
Active Ingredients:
Avobenzone 3.0%
Homosalate 10.0%
Octisalate 5.0%
Octocrylene 10.0%
Purpose: Sunscreen
Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen
FDA Label NDC 68327-074
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cover Fx Skin Care Inc. for the product Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen (NDC 68327-074). 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, use, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Helps prevent sunburn
Warnings
For external use only.
Otc - 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 a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of the 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 at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
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 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.
Other Information
Protect the product in this container from excessive heat and direct sun
Store at 15 – 30 °C
Report serious adverse event to: 575 Fifth Ave 14th Floor, New York, NY10017
Inactive Ingredients
Neopentyl Glycol Diheptanoate, Caprylic/Capric Triglyceride, Dimethicone, Butyloctyl Salicylate, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Acrylates/Dimethicone Copolymer, Cocos Nucifera (Coconut) Fruit Extract, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Bisabolol, Salicornia Herbacea Extract.
Questions?
Call 866-424-3332 M-F 9:00am – 5:00pm EST
Company Information
DIST BY COVER FX SKIN CARE INC.
TORONTO, ONTARIO CANADA M3J 2W8
MADE IN USA
WWW.COVERFX.COM
Product Packaging
COVER FX
SPF 30 BOOSTER DROPS
BROAD SPECTRUM SUNSCREEN
30 mL/1.0 FL OZ
* Please review the disclaimer below.
