LAND SHARK ZINKY SPF 36 AZURE BLUE- zinc oxide cream 
Tropical Seas, Inc.

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Land Shark Zinky Azure Blue

Drug Facts

Active Ingredients

Zinc Oxide 24.0%

Purpose

Sunscreen

Uses

Warnings

For external use only *Keep out of eyes

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

Directions

Inactive Ingredients

ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, flavor, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, glyceryl stearate, cocos nucifera (coconut) fruit extract, cyclopentasiloxane (and) peg-10 dimethicone (and) triethoxycaprylsilan, hydrogenated olive oil, stearyl esters, lauryl lactate, cetyl dimethicone, and mica (and) iron oxides (and) titanium dioxide (and) ferric ferrocyanide.

Principal Display Panel - Label

14g NDC 52854-615-01 Jar Label

14g NDC 52854-615-01 Jar Label

14g NDC 52854-615-01 Blister Card Front 14g NDC 52854-615-01 Blister Card Front

14g NDC 52854-615-01 Blister Card Back 14g NDC 52854-615-01 Blister Card Back

LAND SHARK ZINKY SPF 36 AZURE BLUE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-615
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
CANDELILLA WAX (UNII: WL0328HX19)  
CASTOR OIL (UNII: D5340Y2I9G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LAURYL LAURATE (UNII: GPW77G0937)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
COCONUT (UNII: 3RT3536DHY)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
FERRIC FERROCYANIDE (UNII: TLE294X33A)  
HYDROGENATED OLIVE OIL STEARYL ESTERS (UNII: R37NJ75XVB)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
HYDROGENATED OLIVE OIL (UNII: 53839415GI)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52854-615-0114 g in 1 JAR; Type 0: Not a Combination Product10/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/25/2021
Labeler - Tropical Seas, Inc. (627865660)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Seas, Inc.627865660manufacture(52854-615)

Revised: 10/2023
Document Id: 06c062b6-e037-5e3e-e063-6394a90aba0b
Set id: d23fe61a-3ffb-59d0-e053-2995a90a59e6
Version: 3
Effective Time: 20231002
 
Tropical Seas, Inc.