FDA.reportPublic FDA data

Morphe SPF 30 Broad Spectrum Sunsetter Setting

Product NDC
68577-151
11-digit product format
685770151
Labeler code
68577
Product ID
68577-151_2a268315-4ad3-5f77-e063-6294a90ab671
Type
HUMAN OTC DRUG
Nonproprietary name
Octisalate, Octocrylene, Avobenzone, Homosalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
2; 9; 2; 4.5 mg/100mg; 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
Morphe SPF 30 Broad Spectrum Sunsetter Setting
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2 mg/100mg
HOMOSALATE9 mg/100mg
OCTOCRYLENE2 mg/100mg
OCTISALATE4.5 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal 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
0d34406f-9dd0-3909-e063-6394a90ab9f9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-151-01Morphe SPF 30 Broad Spectrum Sunsetter Setting100 mg in 1 BOTTLE, SPRAYSPRAY1002
68577-151-01Morphe SPF 30 Broad Spectrum Sunsetter Setting1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-151MORPHE SPF 30 BROAD SPECTRUM SUNSETTER SETTING (OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE) SPRAY [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0d34406f-9dd0-3909-e063-6394a90ab9f9.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 253 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nu Skin 180 Degree UV Defense Hydrator SPF 18OCTINOXATE AND ZINC OXIDENSE Products, Inc91a22a5a-87fd-4db0-9183-caebee4013042024-12-24WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incaefd7884-6bc3-4b0b-ba36-1f3e8fe49f932024-12-23WarningsExact identifier
application number: M020
Attitude mineral sunscreen tropical SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude56e57ca0-d163-4580-9bca-747acce4d69f2024-12-23WarningsExact identifier
application number: M020
(S)UNDERCOVER SPF 50ZINC OXIDETUBBY TODDdca478a0-c319-68d8-e053-2a95a90a10fc2024-12-23WarningsExact identifier
application number: M020
LOreal Paris Revitalift Triple Power Anti Aging Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Ince7bef1da-ea35-4306-b043-73d566a7e6bb2024-12-23WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc46aa9917-52ac-4c57-afde-366d2d3ca2002024-12-23WarningsExact identifier
application number: M020
La Roche Posay Anthelios UV Clear Daily Invisible Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc1d115945-fa1b-485b-bf53-44308fd1a6302024-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 SunscreenOCTINOXATEL'Oreal USA Products Inc7cc920de-c91f-4040-a0b9-ea216d6f9bd72024-12-23WarningsExact identifier
application number: M020
Kids SPF50Plus Mineral Sunscreen Rollerball Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd3bdda65-bcb4-42d9-84af-d14c7f4421bd2024-12-23WarningsExact identifier
application number: M020
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin ProtectantDIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Ince8539a43-db85-451c-bce8-2c488f3dc40d2024-12-23WarningsExact identifier
application number: M020
NYX Professional Makeup Buttermelt Glaze SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30HOMOSALATE,OCTISALATE AND OCTOCRYLENELOreal USA Products Inc81093d80-dcaf-4555-98b2-48ce7eb84d0c2024-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 SunscreenOCTINOXATESICOS ET CIEc634eaab-f014-4155-a40b-9030e358ec122024-12-23WarningsExact identifier
application number: M020
Kids SPF50 Plus Mineral Sunscreen Continuous Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd5ffe993-de8f-4623-a010-9cb8dd70de072024-12-23WarningsExact identifier
application number: M020
CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc8b298516-70df-47ab-834f-51dcde28a43a2024-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE6a14ee23-28c9-4704-8af9-d1c4db0d92562024-12-23WarningsExact identifier
application number: M020
Walgreens SPF 50 HydratingAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf347588d-8225-45a7-e053-2995a90ab6882024-12-22WarningsExact identifier
application number: M020
Mineral SunstickZINC SPF STICKTubby Todd29e41fe8-4e17-dbaa-e063-6294a90a4a102024-12-22WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE SPF 50Tubby Todd29e487da-5312-8192-e063-6294a90ad8092024-12-22WarningsExact identifier
application number: M020
EcoStick Sunscreen SPF 35ZINC OXIDE, TITANIUM DIOXIDEStream2Sea, LLCeba17b7a-5e96-4462-9b71-44c2bc577dce2024-12-21WarningsExact identifier
application number: M020
Planet Protecting Sunscreen 30TITANIUM DIOXIDEStream2Sea, LLC89e44c5f-121e-4fdd-b9e0-023909ea32f52024-12-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68577-151-01685770151011 BOTTLE, SPRAY in 1 CARTON (68577-151-01) / 100 mg in 1 BOTTLE, SPRAY2023-06-01NoNoCurrent