FDA.reportPublic FDA data

COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN

Manufacturer
AS Beauty Group LLC
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:47:24

Label at a glance#

ProductCOVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure10 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%

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Uses

  • Helps prevent sunburn
  • if used as directedwith other sunprotection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctorif 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

DOSAGE & ADMINISTRATION SECTION

Apply liberally to skin 15 minutes before sun exposure.

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74884-074COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [AS BEAUTY GROUP LLC]6Unmatched20241207_08a4f199-373f-2a4b-e063-6394a90aeaed.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
74884-07474884-074-02, 74884-074-01

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
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
COCONUT3RT3536DHYIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
440ebee3-134f-24d9-e063-6394a90a295b08a4f199-373f-2a4b-e063-6394a90aeaed2025-11-20WarningsExact identifier
spl set id: 08a4f199-373f-2a4b-e063-6394a90aeaed

Reported adverse events (FAERS/openFDA)#

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