LAND SHARK ZINKY SPF 36 PACIFIC PURPLE- zinc oxide cream

Land Shark Zinky SPF 36 Pacific Purple by

Drug Labeling and Warnings

Land Shark Zinky SPF 36 Pacific Purple by is a Otc medication manufactured, distributed, or labeled by Tropical Seas, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide 24.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

• Apply nosecoat to cheeks, nose, and other areas. Apply a liberal coating of your favorite color, but do not rub into your skin. You want a thick noticable color coat on the area. For ultimate protection, apply on top of our Land Shark Sunscreen lotions or sprays 15 minutes prior to sun exposure!
• Reapply after 80 minutes of swimming or sweating or more often if you burn easily or have sensitive skin.
• 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 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

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 Blister Card Front

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

INGREDIENTS AND APPEARANCE

LAND SHARK ZINKY SPF 36 PACIFIC PURPLE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52854-645
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52854-645-01	14 g in 1 JAR; Type 0: Not a Combination Product	10/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/25/2021

Labeler - Tropical Seas, Inc. (627865660)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Seas, Inc.		627865660	manufacture(52854-645)