PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50

Manufacturer
Elemis Ltd. | Elemis Ltd
Effective date
2025-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:17:02

Label at a glance#

ProductPRO-COLLAGEN SKIN PROTECTION FLUID SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure14 sections

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

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0 %

Homosalate 5.0 %

Octisalate 5.0 %

Octocrylene 7.0%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

• helps prevent sunburn

• higher SPF gives more sunburn protection

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

• on damaged or broken skin

OTC - WHEN USING SECTION

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

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.

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.

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Water, Carthamus Tinctorius (Safflower) Oleosomes, Glycerin, Propylheptyl Caprylate, Coco-Caprylate/Caprate, Undecane, Triheptanoin, Sodium Stearoyl Glutamate, Hydroxyacetophenone, Tridecane, Hydrolyzed Jojoba Esters, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Cetearyl Alcohol, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Cetyl Palmitate, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan Palmitate, Gluconolactone, Sodium Citrate, Pentylene Glycol, Padina Pavonica Thallus Extract, Sodium Phytate, Sodium Benzoate, Sorbitan Oleate, Castor Oil/IPDI Copolymer, Citric Acid, Sodium Hydroxide, Collagen Amino Acids, Cyamopsis Tetragonoloba (Guar) Gum, Fructooligosaccharides, Phytic Acid, Leuconostoc/Radish Root Ferment Filtrate, Bioflavonoids, Glycoproteins.

OTC - QUESTIONS SECTION

US T: 1-855-235-3647

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pro-Collagen Skin Protection Fluid SPF 50

Broad Spectrum SPF 50 Sunscreen

Protects, primes and brightens

40 ml e 1.3 US fl.oz.

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.elemis.com/Package Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65912-012-40PRO-COLLAGEN SKIN PROTECTION FLUID SPF 501 in 1 CARTONCREAM12
65912-012-40PRO-COLLAGEN SKIN PROTECTION FLUID SPF 5040 g in 1 TUBECREAM402
65912-012-41PRO-COLLAGEN SKIN PROTECTION FLUID SPF 5040 g in 1 TUBECREAM402

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65912-01265912-012-40, 65912-012-41

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Source Document#

Source XML

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 SKIN PROTECTION FLUID SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEElemis Ltd.23f9222f-60ba-72fb-e063-6394a90a99652025-11-20WarningsExact identifier
ndc (package): 65912-012-41
ndc (package): 65912-012-40
ndc (product): 65912-012
ndc11 (package): 65912001241
ndc11 (package): 65912001240
spl id: 440ead21-3238-12ec-e063-6394a90a4acb
spl set id: 23f9222f-60ba-72fb-e063-6394a90a9965

Reported adverse events (FAERS/openFDA)#

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