PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50- avobenzone, homosalate, octisalate and octocrylene cream

PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50 by

Drug Labeling and Warnings

PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50 by is a Otc medication manufactured, distributed, or labeled by Elemis Ltd., Elemis Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Avobenzone 3.0 %

Homosalate 5.0 %

Octisalate 5.0 %

Octocrylene 7.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

helps prevent sunburn

higher SPF gives more sunburn protection

WARNINGS

For external use only

DO NOT USE

on damaged or broken skin

WHEN USING

keep out of eyes. Rinse with water to remove.

STOP USE

rash occurs

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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 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

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

INACTIVE INGREDIENT

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.

QUESTIONS

US T: 1-855-235-3647

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.

INGREDIENTS AND APPEARANCE

PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50 
avobenzone, homosalate, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65912-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mg  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CASTOR OIL/IPDI COPOLYMER (UNII: GSA2TXZ34G)
C9-12 ALKANE (UNII: 7J5R5W72QM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
UNDECANE (UNII: JV0QT00NUE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GUAR GUM (UNII: E89I1637KE)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TRIDECANE (UNII: A3LZF0L939)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FYTIC ACID (UNII: 7IGF0S7R8I)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
PHYTATE SODIUM (UNII: 88496G1ERL)
PADINA PAVONICA (UNII: 177U06NHZI)
HYDROLYZED CORN PROTEIN (ENZYMATIC; 1500 MW) (UNII: KWE2Y6VN8Q)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65912-012-40	1 in 1 CARTON	01/01/2025
1		40 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65912-012-41	40 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2025

Labeler - Elemis Ltd. (399838895)

Registrant - Elemis Ltd (399838895)