I-MAX EXCELLENCE- avobenzone octinoxate oxybenzone lotion 
MAXLIFE USA, 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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ACTIVE INGREDIENTS:

AVOBENZONE 2.5%

OCTINOXATE 7.5%

OXYBENZONE 5%

PURPOSE:

SUNSCREEN

USES:

HELPS PREVENT SUNBURNS. HIGHER SPF GIVES MORE SUNBURN PROTECTION.

WARNINGS

WARNINGS:

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN.

WHEN USING THIS PRODUCT

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

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.

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 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? 1-323-733-7033

30_SPF Lotion_Label_2012-03-15

30_SPF Lotion_Label_2012-05-23

I-MAX EXCELLENCE 
avobenzone octinoxate oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42952-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42952-101-1259 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/15/2012
Labeler - MAXLIFE USA, INC. (785111431)
Registrant - MAXLIFE USA, INC. (785111431)
Establishment
NameAddressID/FEIBusiness Operations
CUSTOM RESEARCH LABS INC028611598manufacture(42952-101)

Revised: 11/2018
Document Id: 98fc49ff-0f37-48e8-99e7-4060418c5aca
Set id: 0a654c5f-32c0-4599-91c3-1f17877aa8cb
Version: 9
Effective Time: 20181107
 
MAXLIFE USA, INC.