Expedition Backcountry Spf 30 Spray

Expedition Backcountry Spf 30 Spray
SPL v6
SPL
SPL Set ID b5e4e63c-3e51-0a78-e053-2a95a90abd87
Route
TOPICAL
Published
Effective Date 2020-12-07
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
Abies Balsamea Leaf Oil Eucalyptus Oil Achillea Millefolium Root Oil Litsea Oil 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 Citronella Oil Pogostemon Cablin Leaf Oil Lavandin Oil Camphor Oil Orange Oil

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 5.0%

Octisalate 3.0%

Avobenzone 2.5%

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, citronella oil, eucalyptus oil, fir needle oil, lavandin oil, litsea oil, camphor oil, patchouli oil, yara yara, and orange oil.

Questions Or Comments?

Call toll free 1-800-368-7327

Principal Display Panel Bottle Label

180ml NDC 52854-326-01


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 5.0%

Octisalate 3.0%

Avobenzone 2.5%

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, citronella oil, eucalyptus oil, fir needle oil, lavandin oil, litsea oil, camphor oil, patchouli oil, yara yara, and orange oil.

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 52854-326-01


Advanced Ingredient Data


Raw Label Data

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