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
Ingredient	Strength
AVOBENZONE	10 mg/g
OCTINOXATE	10 mg/g
OCTOCRYLENE	5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3321281e-612b-4305-bf6d-bfab02c65ffb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65912-001-10	Pro-Collagen MarineBroad Spectrum SPF 30	100 g in 1 JAR	CREAM	100	13
65912-001-10	Pro-Collagen MarineBroad Spectrum SPF 30	1 in 1 CARTON	CREAM	1	13
65912-001-11	Pro-Collagen MarineBroad Spectrum SPF 30	100 g in 1 JAR	CREAM	100	13
65912-001-15	Pro-Collagen MarineBroad Spectrum SPF 30	1 in 1 CARTON	CREAM	1	13
65912-001-15	Pro-Collagen MarineBroad Spectrum SPF 30	15 g in 1 TUBE	CREAM	15	13
65912-001-16	Pro-Collagen MarineBroad Spectrum SPF 30	15 g in 1 TUBE	CREAM	15	13
65912-001-17	Pro-Collagen MarineBroad Spectrum SPF 30	15 g in 1 JAR	CREAM	15	13
65912-001-18	Pro-Collagen MarineBroad Spectrum SPF 30	15 g in 1 JAR	CREAM	15	13
65912-001-18	Pro-Collagen MarineBroad Spectrum SPF 30	1 in 1 CARTON	CREAM	1	13
65912-001-30	Pro-Collagen MarineBroad Spectrum SPF 30	30 g in 1 JAR	CREAM	30	13
65912-001-30	Pro-Collagen MarineBroad Spectrum SPF 30	1 in 1 CARTON	CREAM	1	13
65912-001-31	Pro-Collagen MarineBroad Spectrum SPF 30	30 g in 1 JAR	CREAM	30	13
65912-001-50	Pro-Collagen MarineBroad Spectrum SPF 30	50 g in 1 JAR	CREAM	50	13
65912-001-50	Pro-Collagen MarineBroad Spectrum SPF 30	1 in 1 CARTON	CREAM	1	13
65912-001-51	Pro-Collagen MarineBroad Spectrum SPF 30	50 g in 1 JAR	CREAM	50	13
65912-001-52	Pro-Collagen MarineBroad Spectrum SPF 30	50 g in 1 JAR	CREAM	50	13
65912-001-53	Pro-Collagen MarineBroad Spectrum SPF 30	2 in 1 CARTON	CREAM	2	13
65912-001-53	Pro-Collagen MarineBroad Spectrum SPF 30	50 g in 1 JAR	CREAM	50	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65912-001	PRO-COLLAGEN MARINE BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [ELEMIS LIMITED]	11	Current NDC, Legacy NDC, 18 package rows	20241215_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 3 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunski Hot Block Mineral Sunscreen Stick SPF 50	ZINC OXIDE	Stewart Charley Ventures LLC dba Sunski	04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a8	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7e48a3d2-e453-4733-b42b-8bea804cda59	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Lite SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7204c24f-aab6-45eb-9bd4-879f715ba075	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Lite SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7c1e780a-1831-4f49-a92e-e36017d241a2	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	d45614c8-b09c-417b-b691-082ea2149880	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	999b0b17-be73-4d42-b182-ce038f493301	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	adffff46-4cfb-4c0a-b1a6-75220ee193a5	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	13b2b45b-70e1-46ff-8555-48e1fe98c651	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Kids Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	5c2a5ca3-e9eb-48ba-8698-592d2c7aa241	2026-09-01	Warnings	Exact identifier application number: M020
Sunceutical SPF 50 Mineral Face Cream	ZINC OXIDE	Baxter Laboratories Pty. Ltd.	2c408728-a1de-d51e-e063-6294a90ade0b	2026-08-31	Warnings	Exact identifier application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV	BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	Craver Corporation	38d8c1c9-86b5-1edd-e063-6394a90aeb47	2026-08-30	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	5a3a17ff-a7fd-f707-e063-6394a90a3182	2026-08-29	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAM	ZINC OXIDE	ISNTREE Inc.	5a3a59b2-18b6-521b-e063-6294a90a2958	2026-08-29	Warnings	Exact identifier application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	f5eb347f-0d46-4de6-8f3f-9010327678ed	2026-08-28	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen	ZINC OXIDE	Utu Co	59938ace-c97c-d758-e063-6394a90a77e4	2026-08-28	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen Unscented	ZINC OXIDE	Utu Co	5982e790-7cdb-c96c-e063-6394a90a02d4	2026-08-28	Warnings	Exact identifier application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50	ZINC OXIDE	Utu Co	59d1d0ac-2444-d6f9-e063-6294a90ae80c	2026-08-28	Warnings	Exact identifier application number: M020
Hello Bello Mineral Sunscreen SPF 50	ZINC OXIDE	Topiderm, Inc.	54f12764-5c37-4a05-bf96-209fedb93fd1	2026-08-28	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	5a02c540-5b3b-9379-e063-6294a90a00f6	2026-08-27	Warnings	Exact identifier application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65912-001-10	65912000110	1 JAR in 1 CARTON (65912-001-10) / 100 g in 1 JAR	1 jar	2021-09-01	0000-00-00	No	No	Current
65912-001-11	65912000111	100 g in 1 JAR (65912-001-11)	100 g	2021-09-01	0000-00-00	No	No	Current
65912-001-15	65912000115	1 TUBE in 1 CARTON (65912-001-15) / 15 g in 1 TUBE	1 tube	2018-01-19	0000-00-00	No	No	Current
65912-001-16	65912000116	15 g in 1 TUBE (65912-001-16)	15 g	2018-01-19	0000-00-00	No	No	Current
65912-001-17	65912000117	15 g in 1 JAR (65912-001-17)	15 g	2026-05-01		No	No	Current
65912-001-18	65912000118	1 JAR in 1 CARTON (65912-001-18) / 15 g in 1 JAR	1 jar	2026-05-01		No	No	Current
65912-001-30	65912000130	1 JAR in 1 CARTON (65912-001-30) / 30 g in 1 JAR	1 jar	2020-07-31	0000-00-00	No	No	Current
65912-001-31	65912000131	30 g in 1 JAR (65912-001-31)	30 g	2020-07-31	0000-00-00	No	No	Current
65912-001-50	65912000150	1 JAR in 1 CARTON (65912-001-50) / 50 g in 1 JAR	1 jar	2018-01-19	0000-00-00	No	No	Current
65912-001-51	65912000151	50 g in 1 JAR (65912-001-51)	50 g	2018-01-19	0000-00-00	No	No	Current
65912-001-52	65912000152	50 g in 1 JAR (65912-001-52)	50 g	2018-01-19	0000-00-00	Yes	No	Current
65912-001-53	65912000153	2 JAR in 1 CARTON (65912-001-53) / 50 g in 1 JAR	2 jar	2019-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pro-Collagen Marine Broad Spectrum SPF 30	ELEMIS Limited	2026-04-03	HUMAN OTC DRUG LABEL	13
GIFT OF PRO-COLLAGEN ICONS	Elemis Ltd.	2023-06-06	HUMAN OTC DRUG LABEL	1
PRO-COLLAGEN PERFECT DUO	Elemis Ltd.	2023-04-27	HUMAN OTC DRUG LABEL	1
Pro-Collagen TSA Traveller Collection	Elemis Ltd.	2022-12-19	HUMAN OTC DRUG LABEL	3
Soothe & Hydrate Starter Set	Elemis Ltd.	2022-12-14	HUMAN OTC DRUG LABEL	2