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 1 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk	SPF50	Grace And Fire USA Inc.	2735ab0f-5eec-04c5-e063-6394a90aa60e	2026-10-01	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled	SPF50	Grace And Fire USA Inc.	274a0544-6c71-4d91-e063-6394a90a2247	2026-10-01	Warnings	Exact identifier application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	Trilipid Research Institute, LLC	7f34de0a-eeb3-4b71-9abd-53d03266d993	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	6a43173f-41f9-4207-a0db-53bc8db6f4a4	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	d69b4992-d7e6-4bd7-b144-0485e35818a6	2026-09-10	Warnings	Exact identifier application number: M020
Hydra Finish SPF 15	HOMOSALATE, OCTINOXATE	Guinot	4047e8ec-834a-41e6-a144-5649a7718de4	2026-09-10	Warnings	Exact identifier application number: M020
HYDRA BEAUTE SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	806d1e18-a3fc-43df-a52a-a640902d0887	2026-09-10	Warnings	Exact identifier application number: M020
Pur Confort SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	2fe0656f-f924-48da-91bf-d6f3d98e8fd9	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	51f3d6ca-3189-4380-9afb-4259ba878274	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	b0a95379-998a-4cda-bae7-63faf3d6f3c8	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Lait Solaire Corps SPF 20	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Guinot	d9d2cee0-9189-42d0-b1ab-78b97141b128	2026-09-10	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	1226 W AESTHETICS	5b0ef395-a7dd-378e-e063-6394a90a5dce	2026-09-09	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier application number: M020
Baloom 2% Panthenol Hydro Airy Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE	ARSN KOREA	5148b638-f8a4-fa8b-e063-6294a90ac208	2026-09-08	Warnings	Exact identifier application number: M020
Double-Duty Face Moisturizer	MOSITURIZING SUNSCREEN	Jack Black, LLC	672be406-e3a1-47b4-8ef6-ee2b62baae96	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Pineapple Mint	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	0862534c-5f48-4f67-a3b8-0876a667556f	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E	LIP BALM SPF25	Jack Black, LLC	88e8752d-1fbf-4e28-b79d-7c05ecdce842	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	e8730127-2d8d-4b80-ab90-d2f136d9e516	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and Ginger	LIP BALM SUNSCREEN	Jack Black, LLC	d961d22a-2125-41e9-94a3-5b53d12b320f	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Asian Pear	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	acace707-6671-4818-86f2-d9813792157a	2026-09-08	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