I-MAX EXCELLENCE- avobenzone octinoxate oxybenzone lotion

I-MAX EXCELLENCE by

Drug Labeling and Warnings

I-MAX EXCELLENCE by is a Otc medication manufactured, distributed, or labeled by MAXLIFE USA, INC., CUSTOM RESEARCH LABS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

AVOBENZONE 2.5%

OCTINOXATE 7.5%

OXYBENZONE 5%

PURPOSE

PURPOSE:

SUNSCREEN

INDICATIONS & USAGE

USES:

HELPS PREVENT SUNBURNS. HIGHER SPF GIVES MORE SUNBURN PROTECTION.

WARNINGS

WARNINGS:

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

WHEN USING

WHEN USING THIS PRODUCT

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE

STOP USE AND ASK A DOCTOR IF

A RASH OR IRRITATION DEVELOPS AND LASTS. IF SWALLOWED, GET

MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

DIRECTIONS

APPLY TO CLEAN SKIN 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY

AFTER SWIMMING, EXCERCISING OR PERSPIRATION IN THE SUNLIGHT.

CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

ALKYL BENZOATE, ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, C12-15 GLYCERYL STEARATE, CETEARYL PHOSPHATE, ETHYLHEXYLGLYCERIN, MAGNESIUM ALUMINUM SILICATE, PHENOXYETHANOL, PROPYLENE GLYCOL, SODIUM HYDROXIDE, STEARETH-20, STEARYL ALCOHOL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, WATER (AQUA).

QUESTIONS

QUESTIONS? 1-323-733-7033

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

I-MAX EXCELLENCE 
avobenzone octinoxate oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42952-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL PHOSPHATE (UNII: VT07D6X67O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARETH-20 (UNII: L0Q8IK9E08)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42952-101-12	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/15/2012

Labeler - MAXLIFE USA, INC. (785111431)

Registrant - MAXLIFE USA, INC. (785111431)

Establishment
Name	Address	ID/FEI	Business Operations
CUSTOM RESEARCH LABS INC		028611598	manufacture(42952-101)