Label: SUN BUM SPF 50 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 69039-226-01
- Packager: Sun Bum, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 4, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
-
Warnings
Flammable: Contents under pressure. Do not puncture or inciinerate. Do not store at temperatures above 120°F. Do not use in the presence of a flame or spark keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
-
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 well-ventilated area.
- 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 of 15 or higher and other sun protection measures, including:
- Limit time in the sun, especially from 10 am - 2 pm.
- Wear long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- Other Information
- Inactive Ingredients
- Questions or Comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
SUN BUM SPF 50 PREMIUM MOISTURIZING SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-226 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PPG-5-CETETH-20 (UNII: 4AAN25P8P4) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-226-01 177 mL in 1 CAN; Type 0: Not a Combination Product 08/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/26/2017 Labeler - Sun Bum, LLC (028642574)
