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 93 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olay Age Defying Classic Daily Renewal Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company60183a47-fd02-052b-e053-2991aa0a1b5c2025-12-31WarningsExact identifier
application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and NectarZINC OXIDEThe Procter & Gamble Manufacturing Company026dcaee-d33c-b874-e063-6394a90ad2e72025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - TanOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ab56-abaa-42de-e063-6394a90a63102025-12-31WarningsExact identifier
application number: M020
Olay Complete Plus Daily Facial Moisturizer with Sunscreen Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company22f645cf-5182-9e3f-e063-6394a90adc842025-12-31WarningsExact identifier
application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical BreezeZINC OXIDEThe Procter & Gamble Manufacturing Company232032b7-803f-40ec-e063-6394a90a4b382025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Ince1a9a831-a0b9-17ba-e053-2a95a90a3fa72025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ebec-acb0-77c4-e063-6394a90aee072025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc08134b95-1879-27e5-e063-6294a90a29af2025-12-31WarningsExact identifier
application number: M020
Coppertone Oil Free SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incded1f158-36d1-153f-e053-2995a90ace302025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Suncreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc08147940-0e8b-c894-e063-6394a90af8ac2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Ince468d703-fa6c-095a-e053-2a95a90a51942025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc0806bdb9-961f-3146-e063-6294a90a46252025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPL 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incdf4b522e-93d4-1284-e053-2a95a90a1cd92025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc088b7152-d3d1-9e74-e063-6394a90a41522025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc0a5a40ff-a014-3995-e063-6394a90a11e62025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47461ad3-a11e-2a11-e063-6294a90a0f8f2025-12-31WarningsExact identifier
application number: M020
Coppertone Oil Free Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Ince451ecfb-cf17-c622-e053-2a95a90a4d4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc081484f8-58f5-f2a4-e063-6394a90a33792025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Sunscreen SPF 50ZINC OXIDE (24.08%)Beiersdorf Inc09a97e3f-f6dc-eaa7-e063-6294a90ad2742025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Roll-On Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incf3e1ea21-4a07-3e18-e053-2995a90a0fe72025-12-31WarningsExact 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