FDA.reportPublic FDA data

Invisible Sunscreen SPF 40

Manufacturer
COSMAX USA, CORPORATION | COSMAX USA
Effective date
2024-12-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:48:20

Label at a glance#

ProductInvisible Sunscreen SPF 40
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure8 sections

Dosage and administration

Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours 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 other sun protection measures inc...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Homosalate 10%

Octisalate 5%

Avobenzone 3%

Octocrylene 2.6%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Uses

  • Helps prevent sunburn
  • If used as directed with other Sun Protection Measures (see Directions) decrease the risk of skin cancer and early skin aging damaged by the sun

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • 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 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
  • Children under 6 months of age: Ask a doctor

Other information

OTHER SAFETY INFORMATION

Other information

  • Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Isodecane, Ethylhexyl Pamitate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsislsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Sesamum Indicum(Sesame) Seed Extract, Tocopherol, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Lecithin, Fragrance, Silica, Water, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethyl Isosorbide, Sodium Benzoate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SecondarySecondary

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-196-01Invisible Sunscreen SPF 401 in 1 CARTONCREAM11
68577-196-01Invisible Sunscreen SPF 4050 mg in 1 BOTTLE, PLASTICCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-196INVISIBLE SUNSCREEN SPF 40 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [COSMAX USA, CORPORATION]1Current NDC, 2 package rows20241225_29fe531e-2ade-170f-e063-6394a90a1396.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-19668577-196-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SODIUM BENZOATEOJ245FE5EUIACT
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER965K72OQXOIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
ISOMALTS870P55O2WIACT
WATER059QF0KO0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
TOCOPHEROLR0ZB2556P8IACT
ISODODECANEA8289P68Y2IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
SESAME SEED7Y1255HVXRIACT
VITIS VINIFERA FRUIT RIND653OHN32Q1IACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB

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
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENECOSMAX USA, CORPORATION29fe531e-2ade-170f-e063-6394a90a13962024-12-24WarningsExact identifier
ndc (package): 68577-196-01
ndc (product): 68577-196
ndc11 (package): 68577019601
spl id: 29fe2b05-3fc8-f75b-e063-6394a90a0f3d
spl set id: 29fe531e-2ade-170f-e063-6394a90a1396

Reported adverse events (FAERS/openFDA)#

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