WATERBLOCK SOLAR  SPF 30- homosalate, octinoxate, octisalate, octocrylene, and oxybenzone liquid 
Gordon Laboratories, Inc

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.

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Dermalogica®
waterblock
solar spray
spf 30

active ingredients

Homosalate (10.0%), Octinoxate (7.5%), Octisalate (5.0%), Octocrylene (10.0%), Oxybenzone (5.0%).

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

For external use only, not to be swallowed. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

If irritation develops, discontinue use.

Do not use on infants under 6 months old.

Dermalogica, Dist.
Los Angeles, CA 90009 USA

PRINCIPAL DISPLAY PANEL - 125 ml Bottle Carton

waterblock
solar spray

spf 30

4.2 FL OZ / 125 ml e

dermalogica®

Principal Display Panel - 125 ml Bottle Carton
WATERBLOCK SOLAR   SPF 30
homosalate, octinoxate, octisalate, octocrylene, and oxybenzone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-091
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate12.5 mL  in 125 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate9.4 mL  in 125 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate6.25 mL  in 125 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene12.5 mL  in 125 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone6.25 mL  in 125 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21839-091-251 in 1 BOX
1125 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/01/2005
Labeler - Gordon Laboratories, Inc (008328619)

Revised: 10/2011
Document Id: 6f3d5cc8-cae0-47e5-be32-356236a5613f
Set id: 6f06c25e-350b-4a3c-b034-7db00541e03a
Version: 1
Effective Time: 20111026
 
Gordon Laboratories, Inc