COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene oil 
Cover FX Skin Care Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN

Active Ingredients

Active Ingredients:

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%

Purpose: Sunscreen

Use

Helps prevent sunburn

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 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:

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

booster drops

COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68327-074
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SALICORNIA EUROPAEA (UNII: 6ADL50JAKW)  
ARGAN OIL (UNII: 4V59G5UW9X)  
LEVOMENOL (UNII: 24WE03BX2T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
COCONUT (UNII: 3RT3536DHY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68327-074-011 in 1 BOX03/01/2019
130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2019
Labeler - Cover FX Skin Care Inc. (202908021)

Revised: 1/2019
Document Id: 8027e7bb-c18f-d06b-e053-2991aa0a1578
Set id: 8027e7bb-c18e-d06b-e053-2991aa0a1578
Version: 1
Effective Time: 20190123
 
Cover FX Skin Care Inc.