OTC Medication Information: Land Shark SPF 30 Clear Zinc

LAND SHARK SPF 30 CLEAR ZINC- zinc oxide and titanium dioxide cream
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.

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: butterfly nectars (buddleja davidii), thymus vulgaris (thyme), caprylic capric triglyceride, cyclopentasiloxane (and) c30-45 alkylcetearyl dimethicone crosspolymer, c13-16 isoparaffin, c12-14 iso-parrafin, aluminum hydroxide, c13-15 alkane, isostearic acid, octyldodecyl neopentanoate, glycerin, cyclopentasilonane (and) peg/ppg-20/15 dimethicone, phenoxyethanol, caprylyl glycol, sorbic acid, sodium chloride, sorbitan leate, perflurodecalin (o2), 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 — 43 g Jar Label

43g NDC 52854-930-03

43g NDC 52854-930-03 Peel Label
(click image for full-size original)
43g NDC 52854-930-03 Side Label
(click image for full-size original)

LAND SHARK SPF 30 CLEAR ZINC
zinc oxide and titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52854-943
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 7.5 g in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE
WATER
BUDDLEJA DAVIDII LEAF
THYMUS VULGARIS LEAF
CAPRYLIC/CAPRIC ACID
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
C13-16 ISOPARAFFIN
C12-14 ISOPARAFFIN
C13-15 ALKANE
ISOSTEARIC ACID
PEG/PPG-20/15 DIMETHICONE
BIS-PHENYLPROPYL DIMETHICONE (15 CST)
GLYCERIN
OCTYLDODECYL NEOPENTANOATE
PERFLUOROMETHYLDECALIN
PHENOXYETHANOL
CAPRYLYL GLYCOL
SORBIC ACID
SODIUM CHLORIDE
SORBITAN MONOOLEATE
DITETRACYCLINE TETRASODIUM EDETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52854-943-01 43 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/18/2021
Labeler — Tropical Seas, Inc. (627865660)
Establishment
Name Address ID/FEI Operations
Tropical Seas, Inc. 627865660 manufacture (52854-943)

Revised: 11/2021 Tropical Seas, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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