NDC | 76150-148-13 |
Set ID | 2ea94e84-da45-1ab9-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Bell International Laboratories |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients...Purpose
- Uses
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Warnings
For External Use Only
Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120oF. Do not use in the presence of a flame, spark, or while smoking.
Do Not Use on damaged or broken skin. For external use only.
When Using This Product: Do not spray product directly on face. Spray onto hands and rub onto face. Keep out of eyes. Rinse with water to remove.
Stop Use And Ask Doctor if skin rash occures.
Keep Out Of Reach Of Children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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Directions
Apply liberally and evenly 15 minutes prior to sun exposure.
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 Measure: 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 10a.m. to 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sun glasses.
- Inactie Ingredients
- Other Information
- Primary Label with drug facts box
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INGREDIENTS AND APPEARANCE
TAN TOWEL SPF 30 BRONZING MIST BROAD SPECTRUM
sunscreen aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76150-148 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76150-148-13 177 mL in 1 CAN; Type 0: Not a Combination Product 03/21/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/21/2016 Labeler - Bell International Laboratories (967781555)