LAND SHARK ZINKY SPF 36 PACIFIC PURPLE- zinc oxide cream 
Tropical Seas, Inc.

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Land Shark Zinky Pacific Purple

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, synthetic fluorphlogopite (and) titanium dioxide (and) carmine (and) tin oxide.

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 PACIFIC PURPLE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-645
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
HYDROGENATED OLIVE OIL (UNII: 53839415GI)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CANDELILLA WAX (UNII: WL0328HX19)  
CASTOR OIL (UNII: D5340Y2I9G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LAURYL LAURATE (UNII: GPW77G0937)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
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)  
HYDROGENATED OLIVE OIL STEARYL ESTERS (UNII: R37NJ75XVB)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC FERROCYANIDE (UNII: TLE294X33A)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FERROUS OXIDE (UNII: G7036X8B5H)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
PIGMENT RED 5 (UNII: 91OZU993LX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52854-645-0114 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(52854-645)

Revised: 10/2023
Document Id: 06c07069-717c-4827-e063-6294a90ab035
Set id: d240fe7c-9d16-78c9-e053-2a95a90a763c
Version: 3
Effective Time: 20231002
 
Tropical Seas, Inc.