FDA.reportPublic FDA data

Pro-Collagen Marine

Manufacturer
ELEMIS Limited
Effective date
2026-04-03
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:52:54

Label at a glance#

ProductPro-Collagen Marine Broad Spectrum SPF 30
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
Label structure10 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection

Dosage and administration

apply liberally and evenly 15 minutes before sun exposure and as needed children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.0% }
Octinoxate 1.0%}
Octocrylene 0.5%}

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product,

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally and evenly 15 minutes before sun exposure and as needed
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA/WATER/EAU
GLYCERIN
CAPRYLIC/CAPRIC TRIGLYCERIDE
GLYCERYL STEARATE SE
ISONONYL ISONONANOATE
DICAPRYLYL CARBONATE
DIMETHICONE
BUTYL METHOXYDIBENZOYLMETHANE
ETHYLHEXYL METHOXYCINNAMATE
PHENOXYETHANOL
POLYACRYLATE-13
BUTYLENE GLYCOL
CETYL ALCOHOL
HYDROXYACETOPHENONE
STEARIC ACID
TOCOPHERYL ACETATE
COCO-CAPRYLATE
XANTHAN GUM
CHLORPHENESIN
POLYISOBUTENE
FRAGRANCE (PARFUM)
DISODIUM EDTA
TOCOPHEROL
BUTYROSPERMUM PARKII (SHEA)
BUTTER
TRITICUM VULGARE (WHEAT) GERM OIL
CHLORELLA VULGARIS EXTRACT
GLYCERYL POLYACRYLATE
DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT
GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER
LECITHIN
PADINA PAVONICA THALLUS EXTRACT
SODIUM DEHYDROACETATE
POLYSORBATE 20
SORBITAN ISOSTEARATE
GINKGO BILOBA LEAF EXTRACT
INGREDIENT NAME
PORPHYRIDIUM CRUENTUM EXTRACT
MIMOSA TENUIFLORA BARK EXTRACT
ROSA DAMASCENA FLOWER
EXTRACT
COLLAGEN AMINO ACIDS
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
POTASSIUM SORBATE
SODIUM BENZOATE
CITRIC ACID

Questions?

OTC - QUESTIONS SECTION

US T: 1-855-235-3647

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pro-Collagen MarinePro-Collagen Marine

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65912-00165912-001-50, 65912-001-15, 65912-001-51, 65912-001-53, 65912-001-30, 65912-001-31, 65912-001-10, 65912-001-11, 65912-001-52, 65912-001-16, 65912-001-17, 65912-001-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
WHEY PROTEIN HYDROLYSATE237DZG2JLAIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETYL ALCOHOL936JST6JCNIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCO-CAPRYLATE4828G836N6IACT
XANTHAN GUMTTV12P4NEEIACT
CHLORPHENESINI670DAL4SZIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TOCOPHEROLR0ZB2556P8IACT
SHEA BUTTERK49155WL9YIACT
CARROTL56Z1JK48BIACT
WHEAT GERM OIL14C97E680PIACT
CHLORELLA VULGARISRYQ4R60M02IACT
PADINA PAVONICA177U06NHZIIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
POLYSORBATE 207T1F30V5YHIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
GINKGO19FUJ2C58TIACT
PORPHYRIDIUM PURPUREUMK2P8K2558NIACT
ACACIA DECURRENS FLOWER8PHF3LSM61IACT
ROSA CENTIFOLIA FLOWERCS4TE8FF7OIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122025-11-19monthly-update2026-06-03 17:40:26

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pro-Collagen Marine Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limited3321281e-612b-4305-bf6d-bfab02c65ffb2026-04-03WarningsExact identifier
ndc (package): 65912-001-17
ndc (package): 65912-001-52
ndc (package): 65912-001-31
ndc (package): 65912-001-16
ndc (package): 65912-001-11
ndc (package): 65912-001-15
ndc (package): 65912-001-51
ndc (package): 65912-001-50
ndc (package): 65912-001-18
ndc (package): 65912-001-30
ndc (package): 65912-001-10
ndc (package): 65912-001-53
ndc (product): 65912-001
ndc11 (package): 65912000116
ndc11 (package): 65912000153
ndc11 (package): 65912000152
ndc11 (package): 65912000151
ndc11 (package): 65912000118
ndc11 (package): 65912000150
ndc11 (package): 65912000110
ndc11 (package): 65912000111
ndc11 (package): 65912000117
ndc11 (package): 65912000130
ndc11 (package): 65912000131
ndc11 (package): 65912000115
spl id: 4e95bb90-b244-f9cc-e063-6294a90a49b2
spl set id: 3321281e-612b-4305-bf6d-bfab02c65ffb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.