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 286 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bright as Day Mineral SPF50ZINC OXIDEKoco Life LLC1c245a53-4098-62e6-e063-6294a90abf122024-09-23WarningsExact identifier
application number: M020
Pure Protect Mineral Sunscreen Stick SPF50ZINC OXIDEKoco Life LLC22cd5999-9b9a-91a3-e063-6394a90a0da52024-09-23WarningsExact identifier
application number: M020
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Naturaleb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea2024-09-23WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.229dabbc-9043-3c9d-e063-6394a90a56922024-09-21WarningsExact identifier
application number: M020
GLC OG Natural Tinted SPF 30 SunscreenZINC OXIDEGUD LIFE CO. LLC25e1e8ec-e19d-45f7-b339-5d12c2b511d62024-09-18WarningsExact identifier
application number: M020
Target Up and Up Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENETARGET CORPORATIONbad7d56e-662e-0776-e053-2a95a90a0af02024-09-18WarningsExact identifier
application number: M020
Target Up and Up Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONb82b6d0d-616d-f041-e053-2995a90ae6a32024-09-18WarningsExact identifier
application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA LLC43d293f6-e13c-4ee9-89df-2a3ef0034e312024-09-16WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd2203ea22-d12a-99fe-e063-6394a90aca9f2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEAllure Labs22042031-ac8e-1ab2-e063-6394a90a6ed42024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEONESKIN INC.2204e776-b1a1-be15-e063-6294a90af5de2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEAllure Labs2205345b-5e92-37eb-e063-6294a90a6b6c2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEONESKIN INC.2205ec0e-ac3f-299f-e063-6294a90a21742024-09-13WarningsExact identifier
application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf4130277-ea9b-6b25-e053-2a95a90a59be2024-09-13WarningsExact identifier
application number: M020
HEB SPF 50 Tattoo Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6df491d-1fa9-a4c8-e053-6394a90a38662024-09-13WarningsExact identifier
application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENESkin Ai, LLC21cbd5ac-5307-939b-e063-6294a90ac7912024-09-10WarningsExact identifier
application number: M020
Mario Badescu SPF 17AVOBENZONE, OCTINOXATE, OCTOCRYLENEBentley Laboratories LLC0fd51f8d-ee67-48fd-ab98-1fedb03394622024-09-10WarningsExact identifier
application number: M020
Mario Badescu Collagen SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLC0246b11b-f1ba-4f47-91ab-52a6554b94672024-09-10WarningsExact identifier
application number: M020
Mario Badescu The Moisture Magnet SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLCf6d653f5-52a0-42ad-8308-b8d6f57050cc2024-09-10WarningsExact identifier
application number: M020
MARIO BADESCU SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBentley Laboratories LLCfe485d4c-0ded-4061-ac34-77b72d5350902024-09-10WarningsExact 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