B.tan Sun Safe AF SPF 50: Package Insert and Label Information

B.TAN SUN SAFE AF SPF 50- 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 15%, Octisalate 5%, Octocrylene 10%

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

Flammable — Do not use while smoking or near heat or flame.

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 • contents under pressure.
• Do not puncture or incinerate. Do not store at temperature above 120°F.

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

  • Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face • do not apply in windy conditions • use in a well ventilated area. • Reapply: after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • children under 6 months: ask a doctor. • Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m • wear long sleeved shirts, pants, hats, and sunglasses.

Protect this product from excessive heat and direct sun.

Alcohol Denat., Acrylates/Octylacrylamide Copolymer, Stearoxytrimethylsilane, Glycerin, Fragrance (Parfum), Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Simmondsia Chinensis (Jojoba) Seed Oil, Argania Spinosa Kernel Oil, Ascorbic Acid

call 1800-914-3880

Label
(click image for full-size original)

B.TAN SUN SAFE AF SPF 50
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73978-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 15 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
ASCORBIC ACID
TRICAPRIN
GLYCERIN
TOCOPHEROL
STEAROXYTRIMETHYLSILANE
JOJOBA OIL
ARGAN OIL
DIETHYLHEXYL SYRINGYLIDENEMALONATE
OCTYL ACRYLATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73978-007-01 170 g in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 03/17/2021
Labeler — Marque of Brands Americas, LLC (081170908)
Establishment
Name Address ID/FEI Operations
Marque of Brands Americas, LLC 081170908 manufacture (73978-007)

Revised: 03/2021 Marque of Brands Americas, LLC

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