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 4 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Round Lab Holiday Heroes Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.5a0d3a85-caff-a90d-e063-6394a90ad0452026-08-27WarningsExact identifier
application number: M020
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
application number: M020
Hero Force Shield Superlight Sunscreen SPF 30ZINC OXIDEChurch & Dwight Co., Inc.140268a9-adb9-4574-ad82-4a2e924dc8082026-08-26WarningsExact identifier
application number: M020
Juyasuyon Sport Ultra Sunscreen CreamOCTOCRYLENE,OXYBENZONE,AVOBENZONE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangdong Aimu Biological Technology Co., Ltd598cfe9e-6ebe-ad18-e063-6294a90ace222026-08-25WarningsExact identifier
application number: M020
NeoStrata Sheer Hydration Sunscreen Broad Spectrum SPF 40OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.e8cdf9f7-d968-42b3-bcb8-02dee7717fd82026-08-25WarningsExact identifier
application number: M020
JUYASUYON Sport Ultra SunscreenAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd59d97ee0-e416-53e7-e063-6294a90a91532026-08-25WarningsExact identifier
application number: M020
NeoStrata Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.ed495f18-2f8e-4991-b797-82e9f6fc7acb2026-08-25WarningsExact identifier
application number: M020
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59e9279a-2427-d6bc-e063-6394a90ae86e2026-08-25WarningsExact identifier
application number: M020
Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.4739e678-ce51-4863-bb74-2275879e1b472026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(YELLOW)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c3009b-ae16-52e1-e063-6394a90a69ee2026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(PINK)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c68d9b-9aa9-4996-e063-6394a90a48d42026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(BLUE)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c78929-9df7-5212-e063-6394a90a37662026-08-24WarningsExact identifier
application number: M020
Dr Marvel COLOR CHANGING FOUNDATION SPF30ETHYLHEXYL METHOXYCINNAMATEGuangzhou Liyan Cosmetics Technology Co., Ltd.59c8865f-ccee-dd50-e063-6294a90aa1852026-08-24WarningsExact identifier
application number: M020
Exuviance Daily Corrector with Sunsreen Broad Spectrum SPF 35OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.74a998e2-8ebf-436c-aac1-b456cd2e072d2026-08-24WarningsExact identifier
application number: M020
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDEAldi Inc59cbfb14-d9b1-ce93-e063-6394a90ac3122026-08-24Warnings, Adverse reactionsExact identifier
application number: M020
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59ac747a-f9c7-2c18-e063-6394a90a23062026-08-23WarningsExact identifier
application number: M020
Sunski Sol Power Daily Face Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLCb6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c2026-08-21WarningsExact 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