Label: BROAD SPECTRUM SUNSCREEN SPF 30- avobenzone, homosalate, octisalate spray
- NDC Code(s): 72476-948-14
- Packager: Retail Business Services, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 30, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Flammable:
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- apply to all skin exposed to the sun
- hold container 4 to 6 inches from the skin to apply
- 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 and avoid inhalation
- 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 value 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
- children under 6 months of age: Ask a doctor
- Other information
- Inactive ingredients
- Disclaimer
- Adverse Reaction
- Principal Panel Display
-
INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SUNSCREEN SPF 30
avobenzone, homosalate, octisalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-948 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 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-948-14 156 g in 1 CAN; Type 0: Not a Combination Product 10/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/30/2023 Labeler - Retail Business Services, LLC (967989935) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(72476-948) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(72476-948)
