Label: LAND SHARK SPF 40- zinc oxide and titanium dioxide lotion
- NDC Code(s): 52854-403-01
- Packager: Tropical Seas, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
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
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 SPF 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
aqueous extracts of: coconut (cocos nucifera) water, butterfly nectars (buddleja davidii), thymus vulgaris (thyme), lauryl lactate, glyceryl stearate se, phenethyl benzoate, octyl dodecyl citrate crosspolymer, octyl dodecly neopentanoate, cetearyl alcohol, phenoxyethanol (and) caprylyl glycol, benzyl alcohol, ethylhexlglycerin, tocopherol, glycerin, cetyl dimethicone, tricontanyl pvp, cetearyl alcohol & polysorbate-60, xanthan gum, citric acid, cetyl alcohol, perflurodecalin, and fragrance.
- Other Information
- Questions or comments?
- Principal Display Panel - 85 g Tube Art
-
INGREDIENTS AND APPEARANCE
LAND SHARK SPF 40
zinc oxide and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52854-403 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 13 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.2 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) THYMUS VULGARIS LEAF (UNII: GRX3499643) BENZYL ALCOHOL (UNII: LKG8494WBH) TOCOPHEROL (UNII: R0ZB2556P8) LAURYL LACTATE (UNII: G5SU0BFK7O) COCONUT WATER (UNII: 267F5Y81NT) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) WATER (UNII: 059QF0KO0R) BUDDLEJA DAVIDII LEAF (UNII: X380815D32) GLYCERIN (UNII: PDC6A3C0OX) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PERFLUOROMETHYLDECALIN (UNII: VWJ68OB6TM) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYSORBATE 60 (UNII: CAL22UVI4M) XANTHAN GUM (UNII: TTV12P4NEE) PHENETHYL BENZOATE (UNII: 0C143929GK) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52854-403-01 85 g in 1 TUBE; 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(52854-403)
