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 254 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BABYGANICS SPF 50 Plus SUNSCREENZINC OXIDE, OCTISALATE, AND OCTOCRYLENEKAS Direct LLC dba Babyganics4075f9dc-c25f-434f-a3fc-a7f896295c3d2024-12-20WarningsExact identifier
application number: M020
SunscreenHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONETotal Resources International7d4f820d-e154-428e-89c2-2e26e088ceef2024-12-20WarningsExact identifier
application number: M020
Babyganics Sheer Blend SPF50 Mineral SunscreenZINC OXIDEKAS Direct LLC dba BabyGanicsedced0dc-dd43-4ac9-b816-f4edb45fc87b2024-12-20WarningsExact identifier
application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 SunscreenOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION29ad7391-d932-3549-e063-6394a90ab2b22024-12-20WarningsExact identifier
application number: M020
Face Reality daily spf 30 plus Sunscreen SPF 30HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC45a3ce12-15fe-4040-95da-ac8513a39fb92024-12-20WarningsExact identifier
application number: M020
Face Reality mineral matte spf 28 Sunscreen SPF 28ZINC OXIDE, TITANIUM DIOXIDEFace Reality, LLC29b70afe-cf9d-d0ba-e063-6394a90a1cc42024-12-20WarningsExact identifier
application number: M020
Sonage Roux Tinted Day Creme with SPF 30 Sheer Tinted MoisturizerZINC OXIDEASA Universal Inc. dba: Sonagefd14d70c-6cd0-5de6-e053-6294a90a7add2024-12-20WarningsExact identifier
application number: M020
Coola SPF 50 ClassicSUNSCREEN FACE MISTCOOLA LLCd18d0dac-5690-436e-e053-2995a90a02542024-12-20WarningsExact identifier
application number: M020
COOLA Mineral Body SPF 30 Tropical CoconutZINC OXIDECOOLA, LLCeeb5d4f1-8cba-9ef6-e053-2a95a90a823f2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 100% Mineral Antioxidant SunscreenTITANIUM DIOXIDE, ZINC OXIDEOars and Alps LLCf3971b85-a13e-4195-e053-2995a90a73cb2024-12-20WarningsExact identifier
application number: M020
Vacation SPF 30 MineralZINC OXIDEVacation Inc.f69513ae-f210-075f-e053-2a95a90a9b2e2024-12-20WarningsExact identifier
application number: M020
Vacation SPF 30 Chardonnay OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f694752d-4839-3768-e053-2995a90a5d3e2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSprayAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOars and Alps LLCec5b82f5-b36c-fbc5-e053-2995a90afa0c2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 70 Hydrating Antioxidant SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOars and Alps LLCf39673a7-0b62-bdf7-e053-2995a90aa2b72024-12-20WarningsExact identifier
application number: M020
Carpe SPF 30 Face PrimerTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc. DBA Carpefeac5ee2-faa5-fd17-e053-6394a90a7f992024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 MineralZINC OXIDEOars and Alps LLCf395bc39-daa5-53b8-e053-2995a90a5f482024-12-20WarningsExact identifier
application number: M020
Babyganics Kids Sheer Blend SPF50 Mineral SunscreenZINC OXIDEKAS Direct LLC dba BabyGanics8a143645-3b52-4797-9b26-dc9dd63be38f2024-12-20WarningsExact identifier
application number: M020
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESmall World Brandsb1df4c81-333b-450d-963e-6670ab9bbda92024-12-20WarningsExact identifier
application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beigeTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.062fa0d9-f384-48af-8269-42de3a788db12024-12-20WarningsExact identifier
application number: M020
Stokoderm Sunscreen PUREAVOBENZONE, OCTOCRYLENE, OCTISALATE, AND HOMOSALATESC Johnson Professional USA, Inc.3ddf81e6-de78-4f2f-814b-c75eadcddb392024-12-20WarningsExact 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