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 262 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e98c3b64-edcb-16c7-e053-2a95a90a8a0e2024-12-04WarningsExact identifier
application number: M020
Sun ,Bug Handsfree 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8f29aec-935f-e828-e053-6394a90a570a2024-12-04WarningsExact identifier
application number: M020
sunscreen 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f82024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 21ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9585d3d2-806c-36e3-e053-2a95a90a28fa2024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB SPF42 No21OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3d196cf3-eddd-21d7-e054-00144ff88e882024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 23ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.6a81522e-f4d9-4013-8563-f50f01ff63262024-12-04WarningsExact identifier
application number: M020
Milani Prime Protect SPF 30 Face PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONEThe Milani Group, Inc.d557d554-5161-482c-bd78-7721c7dc9a6e2024-12-04WarningsExact identifier
application number: M020
Pipette Diaper RashZINC OXIDEAmyris, Incef5ea6f5-0126-47de-9bee-9070c5f6112b2024-12-04WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc81a889b8-0719-40c9-b8d4-d9220747ce492024-12-04WarningsExact identifier
application number: M020
Bright-eyed 100% mineral Eye Cream Broad Spectrum Sunscreen SPF 40ZINC OXIDESupergoop, LLC971ac413-5e69-7553-e053-2995a90a41682024-12-04WarningsExact identifier
application number: M020
PLAY Antioxidant Body Mist SPF 50 With Vitamin CAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC9c5c0608-3f42-6640-e053-2a95a90a50862024-12-04WarningsExact identifier
application number: M020
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S Ae4bb5a32-c5dc-86d5-e053-2a95a90a49382024-12-04WarningsExact identifier
application number: M020
Burts Bees Firming Day SPF30ZINC OXIDEBurts Beesf028ffea-184b-46db-9e48-dab4a535bf002024-12-03WarningsExact identifier
application number: M020
Burts Bees Calming Day SPF30ZINC OXIDEBurts Beese406e6ba-fa6d-452d-bc29-404e2f8fcf3e2024-12-03WarningsExact identifier
application number: M020
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen AmberZINC OXIDE, TITANIUM DIOXIDEAlumier Labsba864a08-e66d-d286-e053-2995a90a18542024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs2874e531-d647-339c-e063-6394a90ac86f2024-12-03WarningsExact identifier
application number: M020
REEF SAFE Unscented SPF Mineral Sunscreen 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.286965aa-0961-0141-e063-6394a90aa3f02024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer Hydration Tinted Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa951ebe7-7786-38ef-e053-2995a90a70e32024-12-03WarningsExact 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