FDA.reportPublic FDA data

2000DL-CL30T

Product NDC
58418-004
11-digit product format
584180004
Labeler code
58418
Product ID
58418-004_4c12935a-a071-488e-e063-6394a90aa6d3
Type
HUMAN OTC DRUG
Nonproprietary name
SPF30 BS Tropical
Dosage form
LOTION
Route
TOPICAL
Labeler
Epic Laboratories, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
OCTOCRYLENE; AVOBENZONE
Active strength
2.34; .9 g/30mL; g/30mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
2000DL-CL30T
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE2.34 g/30mL
AVOBENZONE.9 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0286f94e-a2e8-b529-e063-6294a90ac08dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-004-062024-08-22C16284748780-11030e365-6919-111a-e063-dadaa90a10e2Tropical scented SPF30 BROAD SPECTRUM LOTION FORMULA #2000-DL-CL30V Oxybenzone free/Octinoxate free
58418-004-062024-07-30C16284748780-11030e365-6919-111a-e063-dadaa90a10e2Tropical scented SPF30 BROAD SPECTRUM LOTION FORMULA #2000-DL-CL30V Oxybenzone free/Octinoxate free
58418-004-062024-01-30C16284748780-11030e365-6919-111a-e063-dadaa90a10e2Tropical scented SPF30 BROAD SPECTRUM LOTION FORMULA #2000-DL-CL30V Oxybenzone free/Octinoxate free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-004-062000DL-CL30T177 mL in 1 TUBELOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-0042000DL-CL30T (SPF30 BS TROPICAL) LOTION [EPIC LABORATORIES, LLC]4Current NDC, 1 package rows20250101_0286f94e-a2e8-b529-e063-6294a90ac08d.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 216 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
natural lip balm SPF15( Birthday cake) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3152bd5d-474f-e392-e063-6294a90aa9302025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Bubble Gum FlavoredLIP BALM SPF15 BUBBLE GUM FLAVOREDLS Promotions Inc3152bd5d-4750-e392-e063-6294a90aa9302025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Cocount Pina Colada) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31538f32-9f71-bd40-e063-6394a90a1cd82025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Birthday Cake flavoredLIP BALM SPF15 BIRTHDAY CAKE FLAVOREDLS Promotions Inc3153bc6a-8f60-ea37-e063-6294a90acd972025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Apple pie) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3153e1fe-1c43-def0-e063-6294a90a6b3a2025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Strawberry Shortcake flavoredLIP BALM SPF15 STRAWBERRY SHORTCAKE FLAVOREDLS Promotions Inc315402e4-c1ec-150f-e063-6294a90ae29e2025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Vanilla) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3154206c-00b3-e5e3-e063-6394a90afee82025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Passion Fruit) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31544568-c556-72b2-e063-6294a90ace912025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Peppermint) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31548583-ecc7-2e1e-e063-6394a90a24022025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( strawberry) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3154b0f0-2025-4514-e063-6394a90a70c42025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Tropical Punch FlavoredLIP BALM SPF15 TROPICAL PUNCH FLAVOREDLS Promotions Inc3154ae45-e075-f53b-e063-6294a90aed5b2025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Passion Fruit flavoredLIP BALM SPF15 PASSION FRUIT FLAVOREDLS Promotions Inc31552e96-980c-8120-e063-6294a90af3da2025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( tropical punch) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.315579e7-e1fb-d6f5-e063-6294a90af06a2025-03-27WarningsExact identifier
application number: M020
Shea MoistureNOURISHED AND RADIANT BROAD SPECTRUM SPF 30 SUNSCREEN FACE LOTIONConopco d/b/a/ Unilever3159be1c-9678-5b1a-e063-6294a90acd082025-03-27WarningsExact identifier
application number: M020
CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Inc7d9e8c07-d295-4c8e-a52f-bdb509dc489b2025-03-27WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Mattifying Oil plus Pore Control SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC8d89ebf5-bcd5-4fde-a7d4-059023e00f332025-03-27WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Brightening SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC4ff8525a-4526-4acf-86c7-88f1f10732742025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 UnflavoredLIP BALM SPF15LS Promotions Inc3131632d-735c-6688-e063-6294a90a02392025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Chocolate Sundae flavoredLIP BALM SPF15LS Promotions Inc3142f352-ee65-47b5-e063-6394a90ada572025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Pina Colada flavoredLIP BALM SPF15 PINA COLADA FLAVOREDLS Promotions Inc31440153-e7ca-1327-e063-6294a90a562c2025-03-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58418-004-0658418000406177 mL in 1 TUBE (58418-004-06) 177 ml2023-10-02NoNoCurrent