LAND SHARK SPF 30- zinc oxide and titanium dioxide lotion 
Tropical Seas, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Zinc Oxide 7.5%

Titanium Dioxide 3.2%

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

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

  • 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 (coco nucifera) water,butterfly nectars (buddleja davidii), thymus vulgaris (thyme), 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, caprylic capric triglyceride, cyclopentasiloxane (and) c30-45 alkylcetearyl dimethicone crosspolymer, c13-16 isoparaffin, c12-14 iso-parrafin, c13-15 alkane, isostearic acid, cyclopentasilonane (and) peg/ppg-20/15 dimethicone, cyclopentasiloxane, bis-phenylpropyl dimeticone, glycerin (coconut derived), octyldodecyl neopentanoate, perflurodecalin (o2), phenoxyethanol, caprilyl glycol, sorbic acid, sodium chloride, sorbitan oleate, and tetrasodium edta.

Other Information

  • protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-368-7327

Principal Display Panel - 120 mL Bottle Label

Land Shark™

Broad Spectrum SPF 30

30

O ​2 ​Renew® Anti-Aging

Transparent • Non-Whitening

Water Resistant (80 Minutes)

Paraben Free • Biodegradable

Mineral Based Sunscreen Lotion

Made with Butterfly Nectars

4 fl. oz. (120ml)

Principal Display Panel - 120 mL Bottle Label
LAND SHARK SPF 30 
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-930
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7.5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCONUT WATER (UNII: 267F5Y81NT)  
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
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)  
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
C12-14 ISOPARAFFIN (UNII: WP37Z9V66A)  
C13-15 ALKANE (UNII: 114P5I43UJ)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PERFLUOROMETHYLDECALIN (UNII: VWJ68OB6TM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52854-930-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/201706/30/2021
2NDC:52854-930-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/202006/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/25/201706/30/2021
Labeler - Tropical Seas, Inc. (627865660)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Seas, Inc.627865660manufacture(52854-930)

Revised: 11/2022
 
Tropical Seas, Inc.