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 13 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP WRMZINC OXIDECOSMAX USA, CORP5647ae2c-bcba-63c0-e063-6394a90ad5bc2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP WRMZINC OXIDECOSMAX USA, CORP56478f3d-f25c-bef7-e063-6294a90ade092026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP COOLZINC OXIDECOSMAX USA, CORP564796f8-072f-61f2-e063-6394a90ab3942026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP COOLZINC OXIDECOSMAX USA, CORP5647e63c-a695-1b40-e063-6394a90a57672026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP NEUTRALZINC OXIDECOSMAX USA, CORP5647d0f1-945f-b0b7-e063-6294a90aafe22026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset SandsZINC OXIDECOSMAX USA, CORP5648da76-5a67-605a-e063-6294a90a4e3b2026-07-10WarningsExact identifier
application number: M020
Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECOSMAX USA, CORP5648d637-9743-97a7-e063-6294a90ad8a12026-07-10WarningsExact identifier
application number: M020
The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla CloudZINC OXIDECOSMAX USA, CORP5648c90b-b814-c16e-e063-6394a90a3e1f2026-07-10WarningsExact identifier
application number: M020
The Mineral Lip One SPF 45 Nourishing Lip Tint Berry BalmyZINC OXIDECOSMAX USA, CORP56490982-200d-e3a7-e063-6394a90a72a42026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Warm SiennaZINC OXIDECOSMAX USA, CORP56491794-712d-1306-e063-6394a90a47072026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Bright BerryZINC OXIDECOSMAX USA, CORP56491833-5053-c85e-e063-6294a90ac4f52026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Nude RoseZINC OXIDECOSMAX USA, CORP56493964-1d5b-2fc7-e063-6394a90a74922026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Soft PetalZINC OXIDECOSMAX USA, CORP5649df7b-9d2c-d8eb-e063-6394a90acf992026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Nude GlowZINC OXIDECOSMAX USA, CORP564a6566-442c-b933-e063-6294a90a6f9b2026-07-10WarningsExact identifier
application number: M020
SOFIE PAVITT FACE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA., CORP564ae5d2-1504-9623-e063-6394a90a2fa52026-07-10WarningsExact identifier
application number: M020
IDEALOVE HYDROGLOW DAILY SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORP564b284c-3248-c6c0-e063-6394a90a11032026-07-10WarningsExact identifier
application number: M020
SOFIE PAVITT FACE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA., CORP564b1ed2-aa98-a334-e063-6294a90a169b2026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOLDEN HOURZINC OXIDECOSMAX USA, CORP564b559e-6fe8-e98e-e063-6294a90a8f0e2026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 BLISS ON THE BEACHZINC OXIDECOSMAX USA, CORP564b63f2-701e-f5bd-e063-6394a90af7972026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOING COCONUTSZINC OXIDECOSMAX USA, CORP564b5ab3-0a7c-f663-e063-6394a90a0c3d2026-07-10WarningsExact 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