NDC | 70820-751-01 |
Set ID | c4503650-242c-43bf-8d55-f240120a9215 |
Category | HUMAN OTC DRUG LABEL |
Packager | Beagle Bioproducts Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- DRUG FACTS
- ACTIVE INGREDIENTS
- USES
- WARNINGS
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DIRECTIONS
• apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use water resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. 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 the time in the sun, especially between 10 a.m.–2 p.m. • wear long sleeve shirts, pants, hats and sunglasses • children under the age of 6 months: ask a doctor - OTHER INFORMATION
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INACTIVE INGREDIENTS
Water, Caprylic/Capric Triglycerides, Tridecyl Neopentanoate, Cyclopentasiloxane, Niacinamide, Anabaena Flosaquae/Aphanizomenon
Flosaquae/Coelosphaerium Kuetzingianum/Microcytis Aeruginosa/Oscillatoria Princeps Extract, Astrocaryum Murumuru Seed Butter, Glycerin, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-15 Alkyl Benzoate, Dimethicone Crosspolymer, Cetearyl Alcohol, Ceteth-20, Glyceryl Stearate, Tapioca Starch Polymethylsilsesquioxane, Sodium Polyacrylate, Laureth-7, Crambe Abyssinica Seed Oil, Sorbitan Oleate, Behenyl Alcohol, Palmitic Acid, Stearic Acid, Lecithin, Lauryl Alcohol, Myristyl Alcohol, Cetyl Alcohol, Glyceryl Dilaurate, Dimethiconol, C13–C16 Isoparaffin, C12–C14 Isoparaffin, C13–C15 Alkane, Tocopheryl Acetate (Vitamin E), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-11, Phenoxyethanol, Caprylyl Glycol, Sodium PCA, Potassium Hydroxide, Fragrance. - Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
CYANTIFIC PROTECTING DAILY BROAD SPECTRUM SPF 30
avobenzone, octinoxate, octisalate, homosalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70820-751 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 10 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 70 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-7 (UNII: Z95S6G8201) CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) DOCOSANOL (UNII: 9G1OE216XY) PALMITIC ACID (UNII: 2V16EO95H1) STEARIC ACID (UNII: 4ELV7Z65AP) LAURYL ALCOHOL (UNII: 178A96NLP2) TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) NIACINAMIDE (UNII: 25X51I8RD4) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) MYRISTYL ALCOHOL (UNII: V42034O9PU) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL DILAURATE (UNII: MFL3ZIE8SK) C13-16 ISOPARAFFIN (UNII: LED42LZG6O) C12-14 ISOPARAFFIN (UNII: WP37Z9V66A) C13-15 ALKANE (UNII: 114P5I43UJ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70820-751-01 1 in 1 BOX 07/08/2016 1 50 mL in 1 BOTTLE; 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 07/08/2016 Labeler - Beagle Bioproducts Inc. (078463068)