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
- Marketing Status: OTC monograph 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 January 14, 2022
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- 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 final part352 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)
