COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene oil

COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN by

Drug Labeling and Warnings

COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Cover FX Skin Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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

INGREDIENTS AND APPEARANCE

COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68327-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68327-074-01	1 in 1 BOX	03/01/2019
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2019

Labeler - Cover FX Skin Care Inc. (202908021)