FDA.reportPublic FDA data

GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35

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 00:48:55

Label at a glance#

ProductGLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure10 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 generously 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 6%

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 generously 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

INACTIVE INGREDIENT SECTION

Inactive ingredients:Water, Butyloctyl Salicylate, Dipropylene Glycol, Methyl Trimethicone,
Biosaccharide Gum-4, Caprylyl Methicone, Propanediol, Bis-Ethylhexyl
Hydroxydimethoxy Benzylmalonate, Betaine, Acrylates Copolymer,
Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone,
Phenoxyethanol, Hydrolyzed Wheat Protein/PVP Crosspolymer, Dibutyl
Lauroyl Glutamide, Dibutyl Ethylhexanoyl Glutamide, Citrus Aurantium
Dulcis (Orange) Peel Oil, Dipotassium Glycyrrhizate, Carbomer, Tocopheryl
Acetate, Aminomethyl Propanol, Butylene Glycol, Hippophae Rhamnoides
Fruit Extract, Disodium EDTA, Pentylene Glycol, Aloe Barbadensis Leaf
Extract, Silica, Bioflavonoids, Potassium Sorbate, Hydroxyphenyl
Propamidobenzoic Acid, Brassica Oleracea Italica (Broccoli) Extract,
Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Ascorbyl Palmitate.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information

  • Protect the product in this container from excessive heat and direct sun

QUESTIONS or COMMENTS

OTHER SAFETY INFORMATION

Questions or comments?

visit www.glossier.com or call toll-free
1-844-OK-GTEAM 1-844-654-8326

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Packaging

Primary PackagePrimary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary Package

Outer CartonOuter Carton

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
68577-152-01GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 3530 mg in 1 BOTTLELOTION302
68577-152-01GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 351 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-152GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0d438692-cd83-ea42-e063-6394a90a862d.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-15268577-152-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTYLENE GLYCOL50C1307PZGIACT
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77IACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIPROPYLENE GLYCOLE107L85C40IACT
METHYL TRIMETHICONES73ZQI0GXMIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
CAPRYLYL TRIMETHICONEH6HK6E4EB1IACT
PROPANEDIOL5965N8W85TIACT
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE7D4Q5YJ8NVIACT
BETAINE3SCV180C9WIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
DIBUTYL LAUROYL GLUTAMIDE3V7K3IA58XIACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
OCTISALATE4X49Y0596WACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
HIPPOPHAE RHAMNOIDES FRUITAVL0R9111TIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
CITRUS BIOFLAVONOIDSBD70459I50IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER 9404Q93RCW27EIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BRASSICA OLERACEA VAR. BOTRYTIS WHOLE87M72T7VW1IACT
ASCORBYL PALMITATEQN83US2B0NIACT

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
GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d438692-cd83-ea42-e063-6394a90a862d2024-12-26WarningsExact identifier
ndc (package): 68577-152-01
ndc (product): 68577-152
ndc11 (package): 68577015201
spl id: 2a269fc1-f19c-8aeb-e063-6294a90a0169
spl set id: 0d438692-cd83-ea42-e063-6394a90a862d

Reported adverse events (FAERS/openFDA)#

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