ISAKNOX SUNCARE 365 ADVANCED SUN- zinc oxide, octinoxate, sulfuric acid cream

ISAKNOX SUNCARE 365 ADVANCED SUN by

Drug Labeling and Warnings

ISAKNOX SUNCARE 365 ADVANCED SUN by is a Otc medication manufactured, distributed, or labeled by LG Household and Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 11.00g/100g

OCTINOXATE 7.00g/100g

TITANIUM DIOXIDE 1.00g/100g

WARNINGS AND PRECAUTIONS

For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.

WHEN USING

Keep out of eyes. Rinse with water to remove.

STOP USE

Stop use if a rash or irritation develops and lasts.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISAKNOX SUNCARE 365 ADVANCED SUN 
zinc oxide, octinoxate, sulfuric acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-393
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE (UNII: DE08037SAB)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PANTHENOL (UNII: WV9CM0O67Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYLPARABEN (UNII: 14255EXE39)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
ADIPIC ACID (UNII: 76A0JE0FKJ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-393-02	1 in 1 BOX
1	NDC: 53208-393-01	70 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/30/2010

Labeler - LG Household and Healthcare, Inc. (688276187)

Registrant - LG Household and Healthcare, Inc. (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
LG Household and Healthcare, Inc.		688276187	manufacture