OTC Medication Information: I-MAX EXCELLENCE

I-MAX EXCELLENCE- avobenzone, octinoxate and 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.

ACTIVE INGREDIENTS:

AVOBENZONE 2.5%

OCTINOXATE 7.5%

OXYBENZONE 5%

PURPOSE:

SUNSCREEN

USES:

HELPS PREVENT SUNBURNS. HIGHER SPF GIVES MORE SUNBURN PROTECTION.

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
(click image for full-size original)

30_SPF Lotion_Label_2012-05-23
(click image for full-size original)
I-MAX EXCELLENCE
avobenzone octinoxate oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42952-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 2.5 g in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALKYL (C12-15) BENZOATE
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
GLYCERYL MONOSTEARATE
CETYL PHOSPHATE
ETHYLHEXYLGLYCERIN
MAGNESIUM ALUMINUM SILICATE
PHENOXYETHANOL
PROPYLENE GLYCOL
SODIUM HYDROXIDE
STEARETH-20
STEARYL ALCOHOL
TETRAHEXYLDECYL ASCORBATE
ALPHA-TOCOPHEROL ACETATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42952-101-12 59 mL in 1 BOTTLE None
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 Operations
CUSTOM RESEARCH LABS INC 028611598 manufacture (42952-101)

Revised: 11/2018 MAXLIFE USA, INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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