Label: LAND SHARK ZINKY SPF 36 AZURE BLUE- zinc oxide cream
- NDC Code(s): 52854-615-01
- Packager: Tropical Seas, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 2, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
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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
- 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!
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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
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INGREDIENTS AND APPEARANCE
LAND SHARK ZINKY SPF 36 AZURE BLUE
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52854-615 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52854-615-01 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(52854-615)
