DEDICATED TO YOUR BUSINESSOTC Certified

We are certified by the FDA for OTC for skincare, color and hair products.

”If you say you’re going to eliminate fine lines and wrinkles, that claim—which alters the form and function and structure of the body—is a medical claim and, therefore, that product is considered a drug by the FDA. It has to be approved and regulated, and there’s a long process to get through,”

Rob Trow, CEO of DermaConcepts, the exclusive US distributor of Environ Skin Care

WHAT'S THE DIFFERENCE?OTC vs. Non-OTC

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Client Satisfaction
Precise Calculation
Quality Control

First, to explain: Cosmetic vs. Drug as defined by the FDA

The FDA addresses the use of drugs and cosmetics under the Federal Food, Drug and Cosmetic Act, enacted in 1938 and amended numerous times to remain current. It draws distinction between cosmetics and drugs.

A cosmetic is defined as any product that is “intended  to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness or altering the appearance.”

A drug is defined as any product that is “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” or any product “intended to affect the structure or any function of the body of humans or other animals.” [FD&C Act, 201 (g)(1)].

Cosmetic & Drug
Some personal care products meet the definitions of both a cosmetic and a drug because they have two intended uses. Among these are anti-dandruff shampoos; deodorant/antiperspirants; skin protectants such as lip balms and diaper ointments, and moisturizers and makeup with sun-protection claims.

OTC Cosmetic or Skincare Product
A Formula that contains active ingredients and in a concentration that may affect the physiology of the human skin is classified as a drug. These OTC (over-the-counter) products must comply with the requirements for both cosmetics and drugs. The product must be made with pharmaceutical-grade ingredients and manufactured in an FDA inspected, cGMP-compliant facility. OTC cosmetic and skincare products are readily available to consumers without a prescription from a healthcare professional.

CONTACT US WITH EASEGet in touch

Come visit our headquarters or simply send us an email anytime you want.
We are open to all communications from our clients.
Address
1111 MacArthur Blvd
Mahwah, NJ 07430
Call us
1 (800) 227-1542
Email us
info@ilabsus.com

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INNOVATIONHeadquarters
Organically grow the holistic world view of disruptive innovation via empowerment.
OUR LOCATIONWhere to find us?
New Jersey: 1111 MacArthur Blvd, Mahwah NJ 07430
INNOVATIONHeadquarters
Organically grow the holistic world view of disruptive innovation via empowerment.
OUR LOCATIONWhere to find us?
https://ilabsus.com/wp-content/uploads/2019/10/img-footer-map.png
New Jersey: 1111 MacArthur Blvd, Mahwah NJ 07430

Copyright 2019 ⓒ INNOVATION LABS, INC | All Rights Reserved| Created by Baro Web Solutions

Copyright 2019 ⓒ INNOVATION LABS, INC | All Rights Reserved| Created by Baro Web Solutions