LAND SHARK SPF 50- octocrylene, octisalate, and avobenzone lotion 
Tropical Seas, Inc.

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Land Shark SPF 50 Oxy Free

Drug Facts

Active Ingredients

Octocrylene 10.0%

Octisalate 5.0%

Avobenzone 3.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

aqueous extracts of: aloe barbadensis leaf extract, algae extract (hawaiian seaplant), chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root & leaf extract, taraxacum officinale (dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis (marshmallow) root extract, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea) extract, phenethyl benzoate, octyl dodecyl citrate crosspolymer, stearic acid, glyceryl stearate se, cetyl dimethicone, glycerin, sodium hydroxide, emulsifying wax, tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, cetyl alcohol, methylparaben, diazolidinyl urea, propylparaben, and caprylyl glycol.

Other Information

Questions or comments?

Call toll free 1-800-368-7327

Principal Display Panel

60 ml NDC: 52854-950-01 60 ml label

120 ml NDC: 52854-950-02 120 ml front label120 ml back label

192 ml NDC: 52854-950-03 192 ml label

946 ml NDC: 52854-950-04 946 ml label

3785 ml NDC: 52854-950-05 3785 ml label

LAND SHARK SPF 50 
octocrylene, octisalate, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-950
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CHAMOMILE (UNII: FGL3685T2X)  
SYMPHYTUM UPLANDICUM LEAF (UNII: D05HXK6R3G)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
AMERICAN GINSENG (UNII: 8W75VCV53Q)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52854-950-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/29/2020
2NDC:52854-950-02120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2020
3NDC:52854-950-03192 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2020
4NDC:52854-950-04946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/29/2020
5NDC:52854-950-053785 mL in 1 JUG; Type 0: Not a Combination Product06/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/14/2020
Labeler - Tropical Seas, Inc. (627865660)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Seas, Inc.627865660manufacture(52854-950)

Revised: 10/2023
Document Id: 06bf8ae7-2cf6-2e8d-e063-6294a90a13ac
Set id: b4cc95f0-d684-5331-e053-2995a90a3295
Version: 4
Effective Time: 20231002
 
Tropical Seas, Inc.