SUN TOTAL PROTECTOR 30 BROAD SPECTRUM SPF 30 DAILY PROTECTION- octinoxate, octisalate, zinc oxide cream

Sun Total Protector 30 broad spectrum SPF 30 daily protection by

Drug Labeling and Warnings

Sun Total Protector 30 broad spectrum SPF 30 daily protection by is a Otc medication manufactured, distributed, or labeled by MD Formulation., Ei Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Acive ingredients:

Octinoxate 7.5%

Octisalate 4.0%

Zinc Oxide 7.8%

Warning:

For external use only. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

Not for resale.

Directions:

Apply to skin prior to sun exposure and reapply as needed.

Labeling

INGREDIENTS AND APPEARANCE

SUN TOTAL PROTECTOR 30 BROAD SPECTRUM SPF 30 DAILY PROTECTION 
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66078-440
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 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARETH-2 (UNII: V56DFE46J5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARETH-100 (UNII: 4OH5W9UM87)
TRICONTANYL POVIDONE (4 TRICONTANYL BRANCHES/REPEAT) (UNII: N0SS3Q238D)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66078-440-03	10.8 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/15/2012

Labeler - MD Formulation. (087008363)

Registrant - Ei Inc. (105803274)

Establishment
Name	Address	ID/FEI	Business Operations
Ei Inc.		105803274	manufacture(66078-440) , label(66078-440)