Label: CELONIA SIGNATURE BIO TONE UP SUN BLOCK- homosalate, octisalate, titanium dioxide, avobenzone cream
- NDC Code(s): 73655-090-01, 73655-090-02
- Packager: Celino Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 10, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Water, Butylene Glycol,Cyclopentasiloxane,EthylhexylPalmitate,Glycerin,Neopentyl Glycol, Diheptanoate,Cyclohexasiloxane,Niacinamide,Caprylyl Methicone,Eclipta Prostrata Extract,Melia Azadirachta Leaf Extract,Human Cord Blood Cell Conditioned Media(100ppm),Moringa Oleifera Seed Oil,Hydrolyzed Vegetable Protein,Salvia Officinalis (Sage) Leaf Extract,Pentylene Glycol,Propanediol,Dimethicone,Triceteareth-4 Phosphate,Glyceryl Stearate,PEG-100 Stearate,Glycol Stearate,Silica,PEG-2 Stearate,Potassium Cetyl Phosphate,Sorbitan Sesquioleate,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Caprylyl Glycol,Glyceryl Caprylate,Tromethamine,Ethylhexylglycerin,Adenosine,Squalane,Maltodextrin,Tocopherol,Sodium Chloride,Sodium Bicarbonate,Glucose,Potassium Chloride,Glutamine,Calcium Chloride,Sodium Phosphate,Sodium Pyruvate,Arginine,Cysteine HCl,Cyanocobalamin,Magnesium Sulfate,Thioctic Acid,Glutamic Acid,Lysine,Isoleucine,Leucine,Ascorbic Acid,Asparagine,Glycine,Threonine,Valine,Proline,Phenylalanine,Histidine,Aspartic Acid,Alanine,Serine,Methionine,Ferrous Sulfate,Guanosine,Tryptophan,Inositol,Calcium Pantothenate,Folic Acid,Pyridoxine HCl,Thiamine HCl,Biotin,Riboflavin,Stearyl Alcohol,Cetyl Alcohol,Xanthan Gum,Disodium EDTA,Tin Oxide (CI 77861),Myristyl Alcohol,Lauryl Alcohol,Fragrance(Parfum),Mica (CI 77019)
- PURPOSE
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WARNINGS
Warnings:
1. Stop using this product and see a dermatologist, if skin swelling, itching or skin rashes appear after using this product or by exposure to sun light
2. Refrain from applying the product on wounded skin area
3. Cautions during storage and handling a) keep out of reach from infants and children b) store away from direct sunlight
4. Wash out immediately when in contact with eyes
- QUESTIONS
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DESCRIPTION
Uses:
Key ingredients: Human cord blood stem cell conditioned media / Defined cell culture media
UV protection of SPF50+ / PA++++
Natural 0.3 tone up effectDirections:
Take desired amount of the product and evenly spread on the skin of sunlight exposure. Re-apply as much as needed upon long exposure to the sunlight for complete protection of your skin after intensive Cell Training
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CELONIA SIGNATURE BIO TONE UP SUN BLOCK
homosalate, octisalate, titanium dioxide, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73655-090 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 5.00 g in 50 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 2.50 g in 50 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 2.13 g in 50 mL Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 1.50 g in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73655-090-02 1 in 1 CARTON 02/01/2020 1 NDC:73655-090-01 50 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2020 Labeler - Celino Inc. (695738827) Registrant - Celino Inc. (695738827) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(73655-090)
