FDA.reportPublic FDA data

Pro-Collagen Marine

Product NDC
65912-001
11-digit product format
659120001
Labeler code
65912
Product ID
65912-001_4e95bb90-b244-f9cc-e063-6294a90a49b2
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, and OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
ELEMIS Limited
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-19
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
10; 10; 5 mg/g; mg/g; mg/g
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
Pro-Collagen Marine
Brand name suffix
Broad Spectrum SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE10 mg/g
OCTINOXATE10 mg/g
OCTOCRYLENE5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal 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
3321281e-612b-4305-bf6d-bfab02c65ffbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65912-001-10Pro-Collagen MarineBroad Spectrum SPF 30100 g in 1 JARCREAM10013
65912-001-10Pro-Collagen MarineBroad Spectrum SPF 301 in 1 CARTONCREAM113
65912-001-11Pro-Collagen MarineBroad Spectrum SPF 30100 g in 1 JARCREAM10013
65912-001-15Pro-Collagen MarineBroad Spectrum SPF 301 in 1 CARTONCREAM113
65912-001-15Pro-Collagen MarineBroad Spectrum SPF 3015 g in 1 TUBECREAM1513
65912-001-16Pro-Collagen MarineBroad Spectrum SPF 3015 g in 1 TUBECREAM1513
65912-001-17Pro-Collagen MarineBroad Spectrum SPF 3015 g in 1 JARCREAM1513
65912-001-18Pro-Collagen MarineBroad Spectrum SPF 3015 g in 1 JARCREAM1513
65912-001-18Pro-Collagen MarineBroad Spectrum SPF 301 in 1 CARTONCREAM113
65912-001-30Pro-Collagen MarineBroad Spectrum SPF 3030 g in 1 JARCREAM3013
65912-001-30Pro-Collagen MarineBroad Spectrum SPF 301 in 1 CARTONCREAM113
65912-001-31Pro-Collagen MarineBroad Spectrum SPF 3030 g in 1 JARCREAM3013
65912-001-50Pro-Collagen MarineBroad Spectrum SPF 3050 g in 1 JARCREAM5013
65912-001-50Pro-Collagen MarineBroad Spectrum SPF 301 in 1 CARTONCREAM113
65912-001-51Pro-Collagen MarineBroad Spectrum SPF 3050 g in 1 JARCREAM5013
65912-001-52Pro-Collagen MarineBroad Spectrum SPF 3050 g in 1 JARCREAM5013
65912-001-53Pro-Collagen MarineBroad Spectrum SPF 302 in 1 CARTONCREAM213
65912-001-53Pro-Collagen MarineBroad Spectrum SPF 3050 g in 1 JARCREAM5013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65912-001PRO-COLLAGEN MARINE BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [ELEMIS LIMITED]11Current NDC, Legacy NDC, 18 package rows20241215_3321281e-612b-4305-bf6d-bfab02c65ffb.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 7 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral Body ShieldZINC OXIDEColorescience52e1f59e-63cb-7480-e063-6394a90ad7c52026-08-10WarningsExact identifier
application number: M020
Eucerin Radiant Tone Tinted Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc596a4204-3d29-9023-e063-6294a90ad99e2026-08-10WarningsExact identifier
application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 SunscreenBEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDEGrace and Fire USA Inc.56ad0dce-410e-9d78-e063-6294a90a1c3e2026-08-09WarningsExact identifier
application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex SunscreenETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangzhou Yapheon Health Industry Co., Ltd.552a36ed-7a66-4048-e063-6394a90a09bc2026-08-08WarningsExact identifier
application number: M020
lip balm SPF15( 2533) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5870aa44-1375-cdc5-e063-6394a90af4a52026-08-07WarningsExact identifier
application number: M020
lip balm SPF15( Zinc oxide) 01ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.5871ab1d-cf07-d737-e063-6394a90a58fe2026-08-07WarningsExact identifier
application number: M020
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40ZINC OXIDECP Skin Health Group, Inc945538b5-5745-42cf-b610-0018ca2ec2542026-08-06WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Stream2Sea Ecostock SPF 40 SunscreenZINC OXIDEStream2Sea, LLC5866e026-a652-3300-e063-6394a90acff02026-08-06WarningsExact identifier
application number: M020
NHLMA Skin Defense SunscreenBROAD SPECTRUM SPF 30NATIONAL HAIR LOSS LLC56326ae0-387f-ad08-e063-6294a90acc4f2026-08-06WarningsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
application number: M020
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65912-001-10659120001101 JAR in 1 CARTON (65912-001-10) / 100 g in 1 JAR1 jar2021-09-010000-00-00NoNoCurrent
65912-001-1165912000111100 g in 1 JAR (65912-001-11) 100 g2021-09-010000-00-00NoNoCurrent
65912-001-15659120001151 TUBE in 1 CARTON (65912-001-15) / 15 g in 1 TUBE1 tube2018-01-190000-00-00NoNoCurrent
65912-001-166591200011615 g in 1 TUBE (65912-001-16) 15 g2018-01-190000-00-00NoNoCurrent
65912-001-176591200011715 g in 1 JAR (65912-001-17) 15 g2026-05-01NoNoCurrent
65912-001-18659120001181 JAR in 1 CARTON (65912-001-18) / 15 g in 1 JAR1 jar2026-05-01NoNoCurrent
65912-001-30659120001301 JAR in 1 CARTON (65912-001-30) / 30 g in 1 JAR1 jar2020-07-310000-00-00NoNoCurrent
65912-001-316591200013130 g in 1 JAR (65912-001-31) 30 g2020-07-310000-00-00NoNoCurrent
65912-001-50659120001501 JAR in 1 CARTON (65912-001-50) / 50 g in 1 JAR1 jar2018-01-190000-00-00NoNoCurrent
65912-001-516591200015150 g in 1 JAR (65912-001-51) 50 g2018-01-190000-00-00NoNoCurrent
65912-001-526591200015250 g in 1 JAR (65912-001-52) 50 g2018-01-190000-00-00YesNoCurrent
65912-001-53659120001532 JAR in 1 CARTON (65912-001-53) / 50 g in 1 JAR2 jar2019-09-010000-00-00NoNoCurrent