FDA.reportPublic FDA data

Cover FX Invisible Primer SPF30

Manufacturer
Cosmax Usa, Corporation
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:59

Label at a glance#

ProductCover FX Invisible Primer SPF30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Apply to all skin exposed to the sun. Children under 6 months: Ask a doctor. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%
HOMOSALATE 10%
OCTISALATE 5%

OCTOCRYLENE 2.6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Apply to all skin exposed to the sun.
  • Children under 6 months: Ask a doctor.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • 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 take other sun protection measures.
  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

ISODODECANE, DIMETHICONE/ BIS-ISOBUTYL PPG-20 CROSSPOLYMER, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, CAPRYLYL METHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, SESAMUM INDICUM (SESAME) SEED EXTRACT, TOCOPHERYL ACETATE, SQUALANE, TOCOPHEROL, SILICA, DIMETHYL ISOSORBIDE.

Questions?

OTC - QUESTIONS SECTION

Email: customerservice@cover fx.com M – F, 10 a.m. – 5 p.m. EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-105-00Cover FX Invisible Primer SPF3030 mL in 1 TUBELOTION305
68577-105-00Cover FX Invisible Primer SPF301 in 1 CARTONLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-105COVER FX INVISIBLE PRIMER SPF30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COSMAX USA, CORPORATION]5Current NDC, 2 package rows20241228_2983dd7c-7ca7-e952-e063-6394a90a3098.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-10568577-105-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISODODECANEA8289P68Y2IACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TOMATOZ4KHF2C175IACT
SESAME SEED7Y1255HVXRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SQUALANEGW89575KF9IACT
TOCOPHEROLR0ZB2556P8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
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
Cover FX Invisible Primer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2983dd7c-7ca7-e952-e063-6394a90a30982024-12-26WarningsExact identifier
ndc (package): 68577-105-00
ndc (product): 68577-105
ndc11 (package): 68577010500
spl id: 2a272a9c-d469-2e6b-e063-6294a90addb6
spl set id: 2983dd7c-7ca7-e952-e063-6394a90a3098

Reported adverse events (FAERS/openFDA)#

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