SUNSCREENS
OVER-THE-COUNTER (OTC) DRUG PRODUCTS

Over-the-counter drugs are substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

These products

  • Do not require a doctor’s prescription
  • Can be purchased off-the-shelf in stores or online
  • Are regulated by FDA through OTC Drug Monographs
POPULAR OTC DRUG PRODUCTS
  • Sunscreen
  • Antidandruff shampoo
  • Toothpaste containing fluoride
  • Antiperspirant deodorant
  • Cold and cough products
  • Hand sanitizers
SUNSCREENS

Sun exposure can cause sunburn, skin aging (such as skin spots, wrinkles, or “leathery skin”), eye damage, and skin cancer, the most common of all cancers.

Skin cancer is on the rise in the U.S. The Centers for Disease Control and Prevention project there will be 106,110 new cases of skin melanomas and 7,180 deaths in 2021.

Skin cancer is the most common form of cancer in the U.S. In 2018, there were an estimated 1.3 million people living with melanoma of the skin in the U.S. About 4.3 million people are treated for basal cell cancer and squamous cell skin cancer in the U.S. every year.

FDA recommends use of broad spectrum sunscreen with sun protection factor (SPF) values of 15 or higher, even on cloudy days.

OTC sunscreen monograph establishes the conditions under which the FDA permits these products to be marketed without approved new drug applications, because they are generally recognized as safe and effective (GRASE), and not misbranded. Two ingredients – zinc oxide and titanium dioxide – are GRASE for use in sunscreens; two ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens due to safety issues.

Products that combine sunscreens with insect repellents are not generally recognized as safe and effective (GRASE).

OTC DRUG ESTABLISHMENT REGISTRATION

Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of an otc drug product for commercial distribution is required to register with FDA.

Products that do not conform to an FDA Monograph require a New Drug Application (NDA).

We expect you to provide

  • Full company name, complete physical address
  • Company DUNS Number
  • Product FDA compliant label, active and inactive ingredients.
LIMITED OFFER
$350.00 ANNUAL SERVICE FEE
USER FEES

$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) (FY 2021). This new fee is additional and required. User Fees are paid to the U.S. Treasury. Manufacturers of hand sanitizers and alcohol wipes are currently exempt.

CONTACT ITB HOLDINGS LLC