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 37 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF Lip ColourZINC OXIDELauren Brooke Cosmetiques, LLC50b344b5-e39d-48ef-e063-6394a90ae41c2026-04-30WarningsExact identifier
application number: M020
No 7 Prime Forever SPF 50 PrimerNO 7 PRIME FOREVER BROAD SPECTRUM SUNSCREEN SPF50 PRIMERBoots Retail USA50b3e9fa-faf8-0026-e063-6294a90a08232026-04-30WarningsExact identifier
application number: M020
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
application number: M020
Moisture Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilcb95975f-060d-23c2-e053-2a95a90adf1b2026-04-30WarningsExact identifier
application number: M020
Day Cream SPF 30OCTOCRYLENE, OCTINOXATE, AVOBENZONEAnthony Skin LLC5070e8cc-12c0-c2c4-e063-6294a90a14222026-04-29WarningsExact identifier
application number: M020
Steak n Shake Beef Tallow Sunscreen SPF 30ZINC OXIDEHRR Enterprises, Inc0eb122d8-6826-4843-bed1-9e0cb8316e6d2026-04-29WarningsExact identifier
application number: M020
EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart509b6c7d-8a28-2d3a-e063-6394a90af0682026-04-29WarningsExact identifier
application number: M020
Freaks of Nature Solar Shield Broad Spectrum SPF 30FREAKS OF NATURE SOLAR SHIELD BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.509b8610-6dbe-611f-e063-6394a90a9fd12026-04-29WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
application number: M020
COTZ FACE MOISTUREZINC OXIDEFallien Cosmeceuticals Ltd.509d9a74-bc8d-c9c1-e063-6394a90a403d2026-04-29WarningsExact identifier
application number: M020
JMSOLUTION MARINE LUMINOUS PEARL SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGPNY CORP212d4563-2fad-31a5-e063-6394a90aff712026-04-29WarningsExact identifier
application number: M020
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Bronze Cell OX Shield Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc5e19577b-9911-4fa1-a2b7-7ca2e02d1fd82026-04-28WarningsExact identifier
application number: M020
Daily Defence Moisturising Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUltraceuticals Pty Ltd50888d3f-46ae-e2c2-e063-6394a90ad6af2026-04-28WarningsExact identifier
application number: M020
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
application number: M020
Fusion Water MagicOCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEISDIN Corp.d4f91d5a-600a-4255-a6e1-e7e7197848c72026-04-28WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Pearl Cell OX Shield Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc6a1b995-1898-4a92-b128-7d5ebd6d8d3d2026-04-28WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC53023b16-8d64-4dfc-bc75-b4f248425c4d2026-04-27WarningsExact identifier
application number: M020
TONEfitSUN Sebum Control Vegan SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory506b96ae-eb2a-edad-e063-6294a90a470e2026-04-27WarningsExact 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