Bb Medium
FDA Label NDC 56001-402

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sayb International for the product Bb Medium (NDC 56001-402). 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 other, active ingredients, purpose, use, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Use

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 30 Ml Tube Carton - Fair

→ Principal Display Panel - 30 Ml Tube Carton - Light

→ Principal Display Panel - 30 Ml Tube Carton - Medium

→ Principal Display Panel - 30 Ml Tube Carton - Dark

Other

Drug Facts

Dist. by SAYB International
CA, 90401 USA

Active Ingredients

Avobenzone, 3.0%,
Homosalate, 2.5%,
Octisalate, 5.0%,
Octocrylene, 2.7%

Purpose

Sunscreen

Use

Helps prevent sunburn

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Keep out of eyes. Stop use if irritation occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help right away.

Directions

Apply liberally 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Children under 6 months: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Diethylhexyl Carbonate, Ricinus Communis (Castor) Seed Oil, Glycerin,Ethyl Macadamiate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Hydrogenated Castor Oil, Isododecane, Microcrystalline Wax, Neopentyl Glycol Diheptanoate, Hibiscus Abelmoschus Extract, Squalane, Palmitoyl Tripeptide-38, Tocopheryl Acetate, Magnesium Sulfate, Hexyl Laurate, Polyglyceryl-4 Isostearate, Glyceryl Dibehenate, Tribehenin, Sodium Chloride, Hydroxypropyl Cyclodextrin, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Behenate, Phenylethyl Resorcinol, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin. May Contain (+/-): Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) <21101>