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Drug Facts
Pro-collagen Skin Protection Fluid Spf 50 Cream
FDA Label NDC 65912-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elemis Ltd. for the product Pro-collagen Skin Protection Fluid Spf 50 (NDC 65912-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Avobenzone 3.0 %
Homosalate 5.0 %
Octisalate 5.0 %
Octocrylene 7.0%
Otc - Purpose
Sunscreen
Indications & Usage
• helps prevent sunburn
• higher SPF gives more sunburn protection
Warnings
For external use only
Otc - Do Not Use
• on damaged or broken skin
Otc - When Using
• keep out of eyes. Rinse with water to remove.
Otc - Stop Use
• rash occurs
Otc - 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.
Otc - Questions
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.
* Please review the disclaimer below.
