FDA.reportPublic FDA data

NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40

Manufacturer
COSMAX USA, CORPORATION | COSMAX USA. CORPORATION
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:56

Label at a glance#

ProductNEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure9 sections

Indications and uses

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 cause by the sun

Dosage and administration

Directions apply liberrally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating 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,...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Avobenzone 3%

Homosalate 9.5%

Octisalate 5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

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 cause by the sun

Warnings

WARNINGS SECTION

Warnings

For extenal 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 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 liberrally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • 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 the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water, butyloctyl salicylate, dipropylene glycol, acrylates copolymer, caprylyl methicone, methyl trimethicone, betaine, ammonium acryloyldimethyltaurate/VP copolymer, hydroxyacetophenone, propanediol, phenoxyethanol, hydrolyzed wheat protein/PVP crosspolymer, dibutyl ethylhexanoyl glutamide, dibutyl lauroyl glutamide, carbomer, citrus aurantium dulcis (orange) peel oil, dipotassium glycyrrhizate, tocopheryl acetate, (vitamin E), aminomethyl propanol, caesalpinia spinosa fruit extract, tropaeolum majus flower/leaf/stem extract, disodium EDTA, carnosine, butylene glycol, pentylene glycol, silica, citrus limon (lemon) peel oil, citrus aurantium bergamia (bergamot) fruit oil, biosaccharide gum-4, kappaphycus alvarezii extract, aloe barbadensis leaf extract, lavandula angustifolia (lavender) oil, ethylhexylglycerin, potassium sorbate, citrus bioflavonoids (vitamin P), hydroxyphenyl propamidobenzoic acid, ocimum basilicum (basil) oil, pelargonium graveolens flower oil, brassica oleracea italica (broccoli) extract, ascorbyl palmitate (vitamin C), limonene, linalool, citral.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Packaging

TubeTube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary Package Outer PackageOuter Package

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-157-01NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF401 in 1 CARTONLOTION12
68577-157-01NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF4030 mg in 1 TUBELOTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-157NEORA INVISIBLOC SUNSCREEN GEL BROAD SPECTRUM SPF40 (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0d584736-3f55-2542-e063-6294a90af3cf.zip

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-15768577-157-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRUS LIMON FLOWERING TOP OIL4C38SS0J60IACT
KAPPAPHYCUS ALVAREZIIT479H08K2OIACT
CITRALT7EU0O9VPPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ASCORBYL PALMITATEQN83US2B0NIACT
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LIMONENE, (+/-)-9MC3I34447IACT
CARNOSINE8HO6PVN24WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TROPAEOLUM MAJUS FLOWER7FV667B00BIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PENTYLENE GLYCOL50C1307PZGIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
BROCCOLI SPROUT128UH9LOAEIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LAVENDER OILZBP1YXW0H8IACT
CITRUS BIOFLAVONOIDSBD70459I50IACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIPROPYLENE GLYCOLE107L85C40IACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
BASIL OILZ129UMU8LEIACT
BETAINE3SCV180C9WIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
DIBUTYL LAUROYL GLUTAMIDE3V7K3IA58XIACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
PROPANEDIOL5965N8W85TIACT
DIBUTYL ETHYLHEXANOYL GLUTAMIDE0IAF2L30VSIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ORANGE OILAKN3KSD11BIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT

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
NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d584736-3f55-2542-e063-6294a90af3cf2024-12-26WarningsExact identifier
ndc (package): 68577-157-01
ndc (product): 68577-157
ndc11 (package): 68577015701
spl id: 2a269c4a-c8f1-fb40-e063-6394a90a176d
spl set id: 0d584736-3f55-2542-e063-6294a90af3cf

Reported adverse events (FAERS/openFDA)#

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