Otc - Active Ingredient
ACTIVE INGREDIENTS:
AVOBENZONE 2.5%
OCTINOXATE 7.5%
OXYBENZONE 5%
I-max Excellence
FDA Label NDC 42952-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Maxlife Usa, Inc. for the product I-max Excellence (NDC 42952-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, warnings, otc - when using, otc - stop use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE:
SUNSCREEN
Indications & Usage
USES:
HELPS PREVENT SUNBURNS. HIGHER SPF GIVES MORE SUNBURN PROTECTION.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
WARNINGS:FOR EXTERNAL USE ONLY.
Otc - When Using
WHEN USING THIS PRODUCT
KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
Otc - 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).
Otc - Questions
QUESTIONS? 1-323-733-7033
Package Label.Principal Display Panel
I-MAX
EXCELLENCE
SPF 30
SUNSCREEN
SPF 30 FOR SKIN PROTECTION
2 FL OZ / 59 ML
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