Definitions - Legend for The Derm Directory

Category Definitions
New since 2008

New Product.
Drugs, Devices, and Injecables: FDA approved since 2010.
Skin Care and Sunscreen product lines: New since 2012.

Generic equivalent is available

Generic equivalent is available

FDA approved for pediatric use

FDA approved for pediatric use (≤11 years)

Use in lactating women is 'safe' or 'probably safe'

Use in lactating women is 'safe' or 'probably safe'

Fragrance-free

Fragrance-free

Just for men

Just for men

Published peer-reviewed studies available

Published peer-reviewed studies available

Prescription required

Prescription required

Available  over-the-counter  (retail stores)

Available over-the-counter (retail stores)

Offered private label

Offered private label

Recommended by the Skin Cancer Foundation

Recommended by the Skin Cancer Foundation

Water resistant or waterproof

Water resistant or waterproof

FDA-Assigned Pregnancy Category

Category Definitions

Pregnancy Category A

Pregnancy Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Pregnancy Category B

Pregnancy Category A

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies which have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Pregnancy Category C

Pregnancy Category A

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Pregnancy Category D

Pregnancy Category A

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Pregnancy Category X

Pregnancy Category A

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.