FDA.reportPublic FDA data

Image MD Restoring Lip Enhancer SPF15

Product NDC
60232-3537
11-digit product format
602323537
Labeler code
60232
Product ID
60232-3537_88ede635-3a2c-45af-9e56-854ac5c125d9
Type
HUMAN OTC DRUG
Nonproprietary name
sunscreen
Dosage form
CREAM
Route
TOPICAL
Labeler
Swiss-American CDMO, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-17
Substance
OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
50; 30; 100; 40 g/1000g; g/1000g; g/1000g; g/1000g
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
Image MD Restoring Lip Enhancer SPF15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 g/1000g
AVOBENZONE30 g/1000g
HOMOSALATE100 g/1000g
OCTOCRYLENE40 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e296579e-ba30-4a29-afe0-bb51f863369cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60232-3537-0Image MD Restoring Lip Enhancer SPF1515 g in 1 TUBECREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-3537IMAGE MD RESTORING LIP ENHANCER SPF15 (SUNSCREEN) CREAM [SWISS-AMERICAN CDMO, LLC]2Current NDC, Legacy NDC, 1 package rows20231108_e296579e-ba30-4a29-afe0-bb51f863369c.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 178 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunforgettable Total Protection Sport StickZINC OXIDEColorescienced3c0d2b0-f411-565d-e053-2a95a90a081b2025-10-15WarningsExact identifier
application number: M020
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE HOMOSALATE OCTOCRYLENEEdgewell Personal Care Brands LLC41376da3-5274-b133-e063-6394a90afa132025-10-15WarningsExact identifier
application number: M020
Curology Daily Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECurologyee59d52e-5dc6-4fb4-96d8-0bda40e230092025-10-15WarningsExact identifier
application number: M020
SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSETZINC OXIDEColoresciencef4aa14ed-6c6f-8301-e053-2a95a90a5e232025-10-15WarningsExact identifier
application number: M020
Curology The Lip Balm Broad Spectrum SPF 30 SunscreenZINC OXIDECurology Inc.e441b13f-cb58-457f-e053-2a95a90adab92025-10-15WarningsExact identifier
application number: M020
Curology Everyday Sunscreen Broad Spectrum SPF 30 No-clog UV defenseZINC OXIDECurology39a2a297-3af2-40d3-8b5d-f4eef2487fb22025-10-15WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral SunscreenZINC OXIDEColorescience00d8bf32-aecd-22da-e063-6294a90a75672025-10-15WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 SandZINC OXIDECosmetic Enterprises Ltd253c105b-215b-1e6e-e063-6294a90a11d72025-10-14WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 TanZINC OXIDECosmetic Enterprises Ltd265bbb1a-ba96-6598-e063-6394a90a94152025-10-14WarningsExact identifier
application number: M020
Resist Wrinkle Defense SPF 30 Paulas ChoiceZINC OXIDECosmetic Enterprises Ltdd658fdc7-9dac-47bf-8e83-1433a29a6cf62025-10-14WarningsExact identifier
application number: M020
SPF 50 Face Sunscreen BioelementsAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECosmetic Enterprises Ltd498b16c8-ba54-4a0a-8dbc-4b5cc368e2142025-10-14WarningsExact identifier
application number: M020
Skin Balancing Ultra Sheer Daily Defence SPF 30 Paulas ChoiceAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONECosmetic Enterprises Ltd3bf31626-5580-457b-8a59-cc37f4ab07672025-10-14WarningsExact identifier
application number: M020
Sunscreen Broad Spectrum SPF 30 Light Tropical ScentZINC OXIDECosmetic Enterprises Ltdd8c7b82d-6151-2199-e053-2a95a90a6c202025-10-14WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.412975d8-0b8b-23bf-e063-6294a90a55682025-10-14WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.4129e00b-951d-adbf-e063-6294a90a675e2025-10-14WarningsExact identifier
application number: M020
Sunny Sailor First Mate Face Stick SPF 30ZINC OXIDESUNNY SAILOR LLCc7908385-ff93-4c6c-9462-081c730235712025-10-13WarningsExact identifier
application number: M020
Cloud Brush On Sunscreen SPF 50ZINC OXIDEFUTURE 8 LLC8b1eaf6c-9cd8-4c5e-beac-b8539c332ae32025-10-13WarningsExact identifier
application number: M020
Sunplus Mist Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC951a7bdc-d5c5-4241-a482-c30a4b44f7762025-10-13WarningsExact identifier
application number: M020
Sunplus Mist Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLCda338ba7-7a92-4157-97f4-5ae9cc64853c2025-10-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60232-3537-06023235370015 g in 1 TUBE (60232-3537-0) 15 g2022-03-170000-00-00NoNoCurrent