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 2 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
application number: M020
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
application number: M020
Jack Black Sun Guard Sunscreen SPF45SUNSCREENJack Black, LLC3cc86bb2-05ce-47eb-8c71-f4f116ca58402026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
application number: M020
Jack Black Lavender Lip Balm 0.25ozLIP BALM SUNSCREENJack Black, L.L.C.e8c6a6d9-1093-41f1-87d5-faf8583d43192026-09-08WarningsExact identifier
application number: M020
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8695305-b89d-c21c-e053-6394a90a0e842026-09-08WarningsExact identifier
application number: M020
Sunscreen stickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.e9f963ee-a98c-efc1-e053-2a95a90aaf532026-09-08WarningsExact identifier
application number: M020
SPF30 Sunscreen 01AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5b04751d-32e9-a7e2-e063-6294a90aefbd2026-09-08WarningsExact identifier
application number: M020
Juyasuyon Invisible SunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONEGuangdong Aimu Biological Technology Co., Ltd5ab335b5-bb9e-4642-e063-6294a90a39862026-09-05WarningsExact identifier
application number: M020
No7 Future Renew Defense Shield SPF 50AVOBENZONE, OCTINOXATE, OCTISALATEBCMC41cc2c52-c6a4-611c-e063-6294a90aae012026-09-03WarningsExact identifier
application number: M020
WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALMART, INC.58b5d0ce-9157-9dee-e063-6394a90ab5432026-09-02WarningsExact identifier
application number: M020
Chantecaille Ultra Sun Protection Sunscreen SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Inc6186ea56-7d56-43f5-985d-a012f1296afa2026-09-02WarningsExact identifier
application number: M020
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50AVOBENZONE, BEMOTRIZINOL, OCTISALATEGrace and Fire USA5739c5b9-00d8-75a8-e063-6394a90aa8c72026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC2d5fa597-08a8-41ca-ba9e-b52e41a5c70c2026-09-01WarningsExact 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