Label: SUNOF SUNSCREEN SPF 50- avobenzone, octisalate, octinoxate aerosol
- NDC Code(s): 77418-003-01
- Packager: ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2025
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- Official Label (Printer Friendly)
- Inactive Ingredients
- WARNINGS
- Active Ingredients
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Flammable
Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or 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.
- Keep out of reach of children.
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Directions
Shake well . Hold container 4 or 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 and then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.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 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 board 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.
- Uses
- PURPOSE
- SUN SCREEN SPRAY
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INGREDIENTS AND APPEARANCE
SUNOF SUNSCREEN SPF 50
avobenzone, octisalate, octinoxate aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77418-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) PARFUMIDINE (UNII: A2Q2LHC6MA) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOBUTANE (UNII: BXR49TP611) ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PANTHENOL (UNII: WV9CM0O67Z) ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) 1,3-BIS(DIPHENYLPHOSPHINO)PROPANE (UNII: 44R56E2C68) 1,3-BUTANEDITHIOL (UNII: 85VJA9KBCH) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77418-003-01 200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/05/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/05/2025 Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248) Registrant - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248) Establishment Name Address ID/FEI Business Operations ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI 566218248 manufacture(77418-003)
