Label: PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50- avobenzone, homosalate, octisalate and octocrylene cream
- NDC Code(s): 65912-012-40, 65912-012-41
- Packager: Elemis Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 8, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50
avobenzone, homosalate, octisalate and octocrylene creamProduct 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)
