TOTAL SUN PROTECTION- octinoxate, zinc oxide, octisalate, oxybenzone lotion 
Cosmed, Inc.

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.

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Clinicians Complex Total Sun Protection SPF 30+

Active Ingredients

Octinoxate 7.5% w/w

Zinc Oxide 3.8% w/w

Octisalate 3.0% w/w

Oxybenzone 3.0% w/w

Purpose

Sunscreen

Uses

• Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only. Do not use on damaged or broken skin. Stop use and ask doctor if rash occurs.  If product is swalled, get medical help or contact a Poison Control Center right away.  When using this product keep out of eyes.  Rinse with water to remove.

Keep out of reach of children.

Keep out of reach of children.

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

Protect this product from excessive heat and direct sun

Questions or Comments:

Call 770-965-1022

Inactive Ingredients

Water, Aloe Barbadensis Leaf Extract, PPG-3 Myristyl Ether, Glycol Stearate, Cetyl Alcohol, Polyacrylamide, PVP/Hexadecene Copolymer, Camellia Oleisera Leaf Extract, 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

Total Sun Protection

TOTAL SUN PROTECTION 
octinoxate, zinc oxide, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61352-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE38 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61352-003-01127.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/201301/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/201301/31/2018
Labeler - Cosmed, Inc. (967008038)
Registrant - A.I.G. Technologies, Inc. (171837367)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. Technologies, Inc.171837367manufacture(61352-003) , label(61352-003)

Revised: 2/2018
 
Cosmed, Inc.