B.tan Tropic Like Its Hot SPF 15: Package Insert and Label Information

B.TAN TROPIC LIKE ITS HOT SPF 15- avobenzone, homosalate, octisalate and octocrylene spray
Marque of Brands Americas, LLC

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.

Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 8%

Sunscreen

  • 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.

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. Keep away from face to avoid breathing it.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Apple liberally 15 minutes before sun exposure.
  • Reapply: after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Children under 6 months of age: ask a doctor.
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am-2pm
  • Wear long-sleeved shirts, pants, hats and sunglasses.

Protect this product from excessive heat and direct sun.

Caprylic/ Capric Triglyceride, VP/Hexadecene Copolymer, Silica, C13-14 Alkane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Vitis Vinifera (Grape) Seed Oil, Fragrance (Parfum), Tocopheryl Acetate, Ascorbic Acid, Panthenol, Citrus Paradisi (Grapefruit) Oil, Citrus Reticulata (Tangerine) Peel Oil, Niacinamide (Vitamin B3)

call 1800-914-3880

label
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label 2
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B.TAN TROPIC LIKE ITS HOT SPF 15
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73978-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 mg in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 6 mg in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 mg in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 8 mg in 100 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
GRAPE SEED OIL
PANTHENOL
VINYLPYRROLIDONE/EICOSENE COPOLYMER
ALPHA-TOCOPHEROL ACETATE
ASCORBIC ACID
OLIVE OIL
GRAPEFRUIT OIL
MANDARIN OIL
NIACINAMIDE
C13-15 ALKANE
PHENOXYETHANOL
SILICON DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73978-005-01 236 g in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/11/2021
Labeler — Marque of Brands Americas, LLC (081170908)
Establishment
Name Address ID/FEI Operations
Marque of Brands Americas, LLC 081170908 manufacture (73978-005)

Revised: 02/2021 Marque of Brands Americas, LLC

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