FDA.reportPublic FDA data

GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35

Product NDC
68577-152
11-digit product format
685770152
Labeler code
68577
Product ID
68577-152_2a269fc1-f19c-8aeb-e063-6294a90a0169
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
3; 6; 5 mg/100mg; mg/100mg; mg/100mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 mg/100mg
HOMOSALATE6 mg/100mg
OCTISALATE5 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d438692-cd83-ea42-e063-6394a90a862dAvailable on FDA.report

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

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 272 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f. Holy Hydration Face Cream SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Incb7898d65-df86-580a-e053-2a95a90a5b1b2024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acda604c-27cf-d500-e053-2995a90a5d652024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acb92160-1749-d51b-e053-2995a90a9e872024-11-06WarningsExact identifier
application number: M020
Bondi Sands Toasted Coconut Lip Balm with SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acb8513e-723b-b7d6-e053-2995a90aed522024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free Face SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acda9863-ad9f-e430-e053-2995a90a69a62024-11-06WarningsExact identifier
application number: M020
Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad SpectrumHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONESEORIN COMPANY Co., Ltd.26442417-f238-1fc3-e063-6394a90a6f822024-11-06WarningsExact identifier
application number: M020
Avene Mineral Sunscreen Face and BodyZINC OXIDEPierre Fabre USA Inc.fb5b1e94-bed3-8486-e053-6294a90a3a842024-11-06WarningsExact identifier
application number: M020
Avene Cleanance Mattifying SPF 30ZINC OXIDEPierre Fabre USA Inc.2644f545-0625-7858-e063-6394a90a59632024-11-06WarningsExact identifier
application number: M020
SPF30 CALENDULA SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY64580be7-868c-40fb-b7b8-840b417b25d32024-11-06WarningsExact identifier
application number: M020
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
application number: M020
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
application number: M020
Vivant Day Treatment SPF 15OCTINOXATE 7.50% OCTISALATE 5.00%Vivant Pharmaceuticals, LLC10a95d0a-366f-0611-e063-6294a90abb442024-11-05WarningsExact identifier
application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.1560a6b6-8d4a-6942-e063-6294a90a4a442024-11-04WarningsExact identifier
application number: M020
Bali Body Watermelon Tanning Oil SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd07d96576-fd78-acf3-e063-6394a90af45b2024-11-03WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Dry-Touch Face and Body Sunscreen Broad Spectrum UVA-UVB SPF 50ZINC OXIDEKenvue Brands LLC8f34c1f6-51fe-4719-ba1f-1e23c05e937b2024-11-01WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCc8d6c731-2dfc-71c0-e053-2a95a90aa5b82024-11-01WarningsExact identifier
application number: M020
Hawaiian Tropic Sport Sunscreen Everyday ActiveAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc64918f-df4c-3a5e-e053-2995a90aea4b2024-11-01WarningsExact identifier
application number: M020
Byoma Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEBYOMA LIMITED25de7939-3b18-7f9e-e063-6394a90a23a92024-11-01WarningsExact identifier
application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.cda67d41-d063-4936-a6b9-23376304eb422024-11-01WarningsExact identifier
application number: M020
Dr Edward Krulig New Melan Sunblock SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEKRULIG INTERNATIONAL, INC21c301d2-b283-40e1-bf26-b4bdde2782472024-10-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-152-01685770152011 BOTTLE in 1 CARTON (68577-152-01) / 30 mg in 1 BOTTLE1 bottle2023-06-01NoNoCurrent