FDA.reportPublic FDA data

Fresh Coast SPF 50 Sunscreen

Product NDC
72839-135
11-digit product format
728390135
Labeler code
72839
Product ID
72839-135_29a4fdc0-2bad-5f17-e063-6394a90a9784
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%
Dosage form
LOTION
Route
TOPICAL
Labeler
Derma Care Research Labs, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-26
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength
15; 5; 10; 3 g/100g; g/100g; g/100g; g/100g
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
Fresh Coast SPF 50 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE15 g/100g
OCTISALATE5 g/100g
OCTOCRYLENE10 g/100g
AVOBENZONE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
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
043cadde-ba07-7c77-e063-6394a90abee6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-135-05Fresh Coast SPF 50 Sunscreen142 g in 1 TUBELOTION1422

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-135FRESH COAST SPF 50 SUNSCREEN (AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%) LOTION [DERMA CARE RESEARCH LABS, LLC]2Current NDC, 1 package rows20241222_043cadde-ba07-7c77-e063-6394a90abee6.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 57 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENEOld East Main Co.db876d34-1af9-4e0a-9e9a-32a8b00e94052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENEOld East Main Co.2ea288fe-815d-4568-9592-55ea428448fa2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.cea1c223-c9d4-42ac-8c5b-c0ca647d57a12026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOld East Main Co.00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.8f4a6a31-2fae-42fe-924f-10237c59e7912026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ef48288b-533f-4924-ba12-fc8cb83643d42026-03-02WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.e6976bf4-ad77-4953-858f-4a0ec7f4300c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.b3d2da09-d9c9-4c27-82fe-a434ece2f0992026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ba9331ef-3744-4072-80a2-af95c6f7ee052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.1a53d8d5-e650-4825-8a3b-7cf42c36e3e52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.086dfda5-9fe7-46b4-9964-4977b86cfdd52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ce9a2139-c5c2-43e2-bd51-1f14ace594d92026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Bask SPF 40 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESurfside Skincare, Inc. dba Bask Suncare49a30877-e39f-46a3-e063-6394a90a8dd22026-03-02WarningsExact identifier
application number: M020
Sunscreen SPF30AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf6014a97-12d3-4f42-86de-866a206c6c062026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS VANILLAEpic Laboratories, LLC02488aad-28be-4ffb-e063-6294a90ad01e2026-03-02WarningsExact identifier
application number: M020
2000DL-CL30TSPF30 BS TROPICALEpic Laboratories, LLC0286f94e-a2e8-b529-e063-6294a90ac08d2026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS ORIGINALEpic Laboratories, LLC1872eefd-d702-ac9f-e063-6294a90a24ef2026-03-02WarningsExact identifier
application number: M020
JAYSUING White Birch Moisturizing Sunscreen CreamTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.4c174691-cc32-b2e4-e063-6294a90a0f732026-03-02WarningsExact identifier
application number: M020
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And PrimerZINC OXIDEKypris Beauty LLCa5d5f7bd-d7bf-4a5c-8530-b9d5d74754c32026-02-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72839-135-0572839013505142 g in 1 TUBE (72839-135-05) 142 g2022-05-26NoNoCurrent