Land Shark Spf 15 Spray

Land Shark Spf 15 Spray
SPL v6
SPL
SPL Set ID b5e49c6f-477b-aafc-e053-2a95a90a982a
Route
TOPICAL
Published
Effective Date 2020-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (3 g) Octisalate (2 g) Avobenzone (1 g)
Inactive Ingredients
Phenethyl Benzoate Cyclomethicone 5 Lauryl Lactate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Octyldodecyl Citrate Crosspolymer Alcohol Octyldodecyl Neopentanoate Alkyl (c12-15) Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-07

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.
  • Do not puncture or incinerate. Contents under pressure.
  • Do not store at temperatures above 120° F
Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

Flammable: Do not use near heat, flame, or while smoking

Directions
  • apply liberally 15 minutes before sun exposure
  • do not spray directly on face - spray into hands and apply to face
  • hold approximately 4 - 6 inches from skin to spray
  • rub into skin evenly to ensure appropriate coverage
  • use in a well-ventilated area
  • avoid inhaling or exposing others to spray
  • do not apply in windy conditions
  • 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.
  • store at temp below 90º F and avoid long term storage
  • may stain fabrics or surfaces
Active Ingredients

Octocrylene 3.0%

Octisalate 2.0%

Avobenzone 1.0%

Inactive Ingredients

sd alcohol 40-b, deionized water, lauryl lactate, cyclopentasiloxane, c12-15 alcohols benzoate, acrylates octylacrylamide copolymer, octyldodecyl neopentanoate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, and fragrance.

Questions Or Comments?

Call toll free 1-800-368-7327

Principal Display Panel Bottle Label

180ml NDC 52854-916-01


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.
  • Do not puncture or incinerate. Contents under pressure.
  • Do not store at temperatures above 120° F
Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

Flammable: Do not use near heat, flame, or while smoking

Directions
  • apply liberally 15 minutes before sun exposure
  • do not spray directly on face - spray into hands and apply to face
  • hold approximately 4 - 6 inches from skin to spray
  • rub into skin evenly to ensure appropriate coverage
  • use in a well-ventilated area
  • avoid inhaling or exposing others to spray
  • do not apply in windy conditions
  • 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.
  • store at temp below 90º F and avoid long term storage
  • may stain fabrics or surfaces
Active Ingredients

Octocrylene 3.0%

Octisalate 2.0%

Avobenzone 1.0%

Inactive Ingredients

sd alcohol 40-b, deionized water, lauryl lactate, cyclopentasiloxane, c12-15 alcohols benzoate, acrylates octylacrylamide copolymer, octyldodecyl neopentanoate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, and fragrance.

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-368-7327

Principal Display Panel Bottle Label (Principal Display Panel - Bottle Label)

180ml NDC 52854-916-01


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)