Label: WATERBLOCK SOLAR SPF 30- homosalate, octinoxate, octisalate, octocrylene, and oxybenzone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 21839-091-25 - Packager: Gordon Laboratories, 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 October 26, 2011
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- active ingredients
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other ingredients
Isododecane, Dicaprylyl Ether, Cyclopentasiloxane, Cocoglycerides, Butyloctyl Salicylate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Diisopropyl Adipate, Melissa Officinalis Leaf Extract, Citrus Grandis (Grapefruit) Peel Oil, Retinyl Palmitate, Ascorbyl Palmitate, Limonene, Tocopheryl Acetate, Caprylyl Glycol.
- warnings
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 125 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
WATERBLOCK SOLAR SPF 30
homosalate, octinoxate, octisalate, octocrylene, and oxybenzone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21839-091 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 12.5 mL in 125 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 9.4 mL in 125 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 6.25 mL in 125 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 12.5 mL in 125 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 6.25 mL in 125 mL Inactive Ingredients Ingredient Name Strength Isododecane (UNII: A8289P68Y2) Dicaprylyl Ether (UNII: 77JZM5516Z) Cyclomethicone 5 (UNII: 0THT5PCI0R) Coco-glycerides (UNII: ISE9I7DNUG) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Diisopropyl Adipate (UNII: P7E6YFV72X) Melissa Officinalis Leaf (UNII: 50D2ZE9219) Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Ascorbyl Palmitate (UNII: QN83US2B0N) Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0) Caprylyl Glycol (UNII: 00YIU5438U) Product Characteristics Color YELLOW (Clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21839-091-25 1 in 1 BOX 1 125 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/01/2005 Labeler - Gordon Laboratories, Inc (008328619)