Bo Spf15
FDA Label NDC 59735-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mana Products for the product Bo Spf15 (NDC 59735-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, use, warnings, directions, inactive ingredients, other information, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 3.00%
Octinoxate 7.50%

Use

  • Helps prevens sunburn
  • If used as direced with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin again caused by the sun.

Warnings

  • 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
  • Stop use and ask a docor if rash occurs
  • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use water resistant sunscreen if swimming or sweathing
  • Reapply at least every 2 hours
  • Children under 6 months: ask a doctor
  • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun especially from 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Water (Aqua), Butylene Glycol, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Hydrogenated Vegetable Oil, Glyceryl Stearate, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Oligopepetide-68, Butyrospermum Parkii (Shea) Buter, Theobroma Cacao (Cocoa) Seed Buter, Diethylhexyl Syringylidenemalonate, Ethylhexylglycerin, Coco-Glucoside, Ammonium Acryloyldimethyltaurate/VP Copolyner, Crambe Abyssinica Seed Oil, Olea Europaea (Olive) Fruit Oil, Hydrogenated Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Panthenol, Citrus Unshiu Peel Extract, Nymphaea Alba Flower Extract, Glycerin, Undecylenoyl Phenylalanine, Sodium Palmitoyl Proline, Ceteth-20, PEG-75 Stearate, Sodium Oleate, Steareth-20, Carbomer, Sodium Hydroxide, Disodium EDTA, o-Cymen-5-ol, Phenoxyethanol, Fragrance (Parfum)

Other Information

Protect this product form excessive heat and direct sun

Principal Display Panel

59735-100-01 (59735 100 01)

59735-100-01 (59735 100 01)

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