Land Shark Spf 30 Oxy Free Formula

Land Shark Spf 30 Oxy Free Formula
SPL v6
SPL
SPL Set ID b5570cbd-89f5-65d5-e053-2995a90a54d1
Route
TOPICAL
Published
Effective Date 2020-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5 g) Octisalate (3 g) Avobenzone (2.5 g)
Inactive Ingredients
Aloe Vera Leaf Water Carrageenan Chamomile Symphytum Uplandicum Leaf Comfrey Root Taraxacum Officinale Leaf Echinacea, Unspecified Sambucus Nigra Flower American Ginseng Macrocystis Pyrifera Lavandula Angustifolia Flowering Top Cymbopogon Schoenanthus Top Althaea Officinalis Root Achillea Millefolium Flower Green Tea Leaf Phenethyl Benzoate Stearic Acid Glyceryl Stearate Se Cetyl Dimethicone 150 Glycerin Sodium Hydroxide Cetostearyl Alcohol Polysorbate 60 Tricontanyl Povidone High Density Polyethylene Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Methylparaben Diazolidinyl Urea Propylparaben Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-14

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

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
Other Information
  • protect this product from excessive cold, heat, and direct sun
Active Ingredients

Octocrylene 5.0%

Octisalate 3.0%

Avobenzone 2.5%

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.

Questions Or Comments?

Call toll free 1-800-368-7327

Principal Display Panel

60 ml NDC: 52854-933-01

120 ml NDC: 52854-933-02

192 ml NDC: 52854-933-03

946 ml NDC: 52854-933-04

3785 ml NDC: 52854-933-05


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

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
Other Information
  • protect this product from excessive cold, heat, and direct sun
Active Ingredients

Octocrylene 5.0%

Octisalate 3.0%

Avobenzone 2.5%

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.

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-368-7327

Principal Display Panel

60 ml NDC: 52854-933-01

120 ml NDC: 52854-933-02

192 ml NDC: 52854-933-03

946 ml NDC: 52854-933-04

3785 ml NDC: 52854-933-05


Advanced Ingredient Data


Raw Label Data

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