Label: TOTAL SUN PROTECTION- octinoxate, octisalate, oxybenzone, zinc oxide lotion
- NDC Code(s): 61352-004-01
- Packager: Cosmed Dermaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 14, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
• Apply liberally 15 minutes before sun exposure and as needed
• Reapply:
• After 40 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 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 10am to 2pm
• Wear long sleeve shirts, pants, hats, and sun glasses
• Children under 6 months: Ask a doctor
- Other Information
- Questions or Comments:
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Inactive Ingredients
Water, PPG-3 Myristyl Ether, Aloe Barbadensis Leaf Extract, Glycol Stearate, Cetyl Alcohol, Polyacrylamide, PVP/Hexadecene Copolymer, White Tea (Camellia Oleisera) Leaf Extract, Green Tea (Camellia Sinensis) Leaf Extract, Tocopheryl Acetate, Propylene Glycol, C13-14 Isoparaffin, Decyl Glucoside, Silica, Cetyl Phosphate, Glyceryl Stearate, PEG 100 Stearate, Glycerin, Diazolidinyl Urea, Triethoxycaprylylsilane, Methylparaben, Disodium EDTA, Propylparaben, Laureth-7
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INGREDIENTS AND APPEARANCE
TOTAL SUN PROTECTION
octinoxate, octisalate, oxybenzone, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61352-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 30 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 g zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 40 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5) GLYCOL STEARATE (UNII: 0324G66D0E) CETYL ALCOHOL (UNII: 936JST6JCN) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL PHOSPHATE (UNII: VT07D6X67O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERIN (UNII: PDC6A3C0OX) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) LAURETH-7 (UNII: Z95S6G8201) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61352-004-01 127.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/13/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M 08/01/2013 Labeler - Cosmed Dermaceuticals, Inc. (967008038) Registrant - A.I.G. Technologies, Inc. (086365223) Establishment Name Address ID/FEI Business Operations A.I.G. Technologies, Inc. 086365223 manufacture(61352-004) , label(61352-004)
