FDA.reportPublic FDA data

COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN

Manufacturer
Cover FX Skin Care Inc.
Effective date
2019-01-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:41

Label at a glance#

ProductCOVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure9 sections

Dosage and administration

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 measu...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%

Purpose: Sunscreen

Use

OTC - PURPOSE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

INSTRUCTIONS FOR USE SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 866-424-3332 M-F 9:00am – 5:00pm EST

Company information

SPL UNCLASSIFIED SECTION

DIST BY COVER FX SKIN CARE INC.

TORONTO, ONTARIO CANADA M3J 2W8

MADE IN USA

WWW.COVERFX.COM

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COVER FX

SPF 30 BOOSTER DROPS

BROAD SPECTRUM SUNSCREEN

30 mL/1.0 FL OZ

booster dropsbooster drops

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68327-074-012022-01-28C16284748780-1d6a99b39-6a06-a426-e053-dadaa90af4c2COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68327-074-01COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN1 in 1 BOXOIL11
68327-074-01COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN30 mL in 1 BOTTLE, GLASSOIL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68327-074COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [COVER FX SKIN CARE INC.]1Legacy NDC, 2 package rows20190301_8027e7bb-c18e-d06b-e053-2991aa0a1578.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68327-07468327-074-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICORNIA EUROPAEA6ADL50JAKWIACT
ARGAN OIL4V59G5UW9XIACT
LEVOMENOL24WE03BX2TIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
COCONUT3RT3536DHYIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8027e7bb-c18f-d06b-e053-2991aa0a15788027e7bb-c18e-d06b-e053-2991aa0a15782019-01-23WarningsExact identifier
spl id: 8027e7bb-c18f-d06b-e053-2991aa0a1578
spl set id: 8027e7bb-c18e-d06b-e053-2991aa0a1578

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.