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 319 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosehip and Lemongrass Lip SPF 15ZINC OXIDEEminence Organic Skin Care4354171a-fd25-4c56-a67c-d48194ea98902023-11-30WarningsExact identifier
application number: M020
SOOTHE Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields9acbf663-15e4-4572-a267-56afa58a347b2023-11-30WarningsExact identifier
application number: M020
EltaMD UV Facial SPF30 PlusZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.8426b0a0-ecd6-4486-b2da-57a950b46dc52023-11-30WarningsExact identifier
application number: M020
Eminence Bright Skin Starter Set KitZINC OXIDEEminence Organic Skin Care6335dfaf-ebdf-4b7b-999e-fabeeaa907ed2023-11-29WarningsExact identifier
application number: M020
Cetaphil Healthy Radiance Whipped Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.69cdf676-34f6-4864-a2a6-9f547b0b45a02023-11-28WarningsExact identifier
application number: M020
Walgreens SPF 30 Premium Moisturizing Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0b24d878-065b-008c-e063-6394a90aa2cf2023-11-27WarningsExact identifier
application number: M020
UNBLEMISH Invisible Matte DefenseHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERodan & Fields9dfe7d50-f347-4671-9657-5e4fbe42b4412023-11-27WarningsExact identifier
application number: M020
SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aacafca-baf7-9a22-e063-6394a90a2ca92023-11-21WarningsExact identifier
application number: M020
SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aad5ced-f356-e294-e063-6394a90aa8d52023-11-21WarningsExact identifier
application number: M020
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0aaeaf00-a438-8164-e063-6394a90a88362023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0ab169df-a760-8978-e063-6394a90ac2f42023-11-21WarningsExact identifier
application number: M020
Sun X SPF 50 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMCoreTex Products, INCc0355990-b842-47cd-e053-2a95a90a7c822023-11-20WarningsExact identifier
application number: M020
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0a9b61ac-4f48-8399-e063-6394a90a43fe2023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a9c1b3f-656d-0d62-e063-6394a90a47312023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Zinc Oxide Sunscreen Broad Spectrum SPF 50ZINC OXIDERite Aid0a9c37b1-6df3-37c6-e063-6394a90ac8c32023-11-20WarningsExact identifier
application number: M020
SPF 15 Lip and SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.0b385246-dc77-6874-e063-6394a90a59592023-11-20WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
application number: M020
Alba Botanica Maximum Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Inc02ba8b03-a1fc-608f-e063-6394a90a06a82023-11-16WarningsExact identifier
application number: M020
Alba Botanica Hawaiian SPF 50 CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Incf693699d-716c-af7f-e053-2a95a90af11a2023-11-16WarningsExact 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