TOTAL SUN PROTECTION- octinoxate, octisalate, oxybenzone, zinc oxide lotion

Total Sun Protection by

Drug Labeling and Warnings

Total Sun Protection by is a Otc medication manufactured, distributed, or labeled by Cosmed Dermaceuticals, Inc., A.I.G. Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5% w/w

Octisalate 3.0% w/w

Oxybenzone 3.0% w/w

Zinc Oxide 4.0% 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. When using this product keep out of eyes.  Rinse with water to remove. Stop use and ask doctor if rash occurs.  Keep out of reach of children.  If product is swalled, get medical help or contact a Poison Control Center right away. 

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, 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOTAL SUN PROTECTION 
octinoxate, octisalate, oxybenzone, zinc oxide lotion

Product 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. (171837367)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc.		171837367	manufacture(61352-004) , label(61352-004)