Label: EXPEDITION BACKCOUNTRY SPF 30- octocrylene, octisalate, and avobenzone spray
- NDC Code(s): 52854-326-01
- Packager: Tropical Seas, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 2, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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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
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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
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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.
- Other Information
- Questions or comments?
- Principal Display Panel - Bottle Label
-
INGREDIENTS AND APPEARANCE
EXPEDITION BACKCOUNTRY SPF 30
octocrylene, octisalate, and avobenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52854-326 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC) EUCALYPTUS OIL (UNII: 2R04ONI662) ACHILLEA MILLEFOLIUM ROOT OIL (UNII: 0S45F449MJ) LITSEA OIL (UNII: 2XIW34BN6O) PHENETHYL BENZOATE (UNII: 0C143929GK) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LAURYL LACTATE (UNII: G5SU0BFK7O) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) ALCOHOL (UNII: 3K9958V90M) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CITRONELLA OIL (UNII: QYO8Q067D0) POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) LAVANDIN OIL (UNII: 9RES347CKG) CAMPHOR OIL (UNII: 75IZZ8Y727) ORANGE OIL (UNII: AKN3KSD11B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52854-326-01 180 mL in 1 CAN; Type 0: Not a Combination Product 12/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/07/2020 Labeler - Tropical Seas, Inc. (627865660) Establishment Name Address ID/FEI Business Operations Tropical Seas, Inc. 627865660 manufacture(52854-326)
