SPOT DEFY- sulfur lotion

Spot Defy by

Drug Labeling and Warnings

Spot Defy by is a Otc medication manufactured, distributed, or labeled by Bioelements. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredient

sulfur 5%

purpose

acne treatment

indications

clears acne pimples

warnings

for external use only.

keep out of reach of children.

when using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time.

do not use on broken skin or large areas of the skin.

when using this product apply only to areas with acne.

directions

clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer at night. if bothersome dryness or peeling occurs, reduce application to every other night.

inactive ingredients

Water (Aqua, Eau), Kaolin, Cetearyl Alcohol, Glyceryl Stearate SE, Glycerin, Butylene Glycol, Bentonite, Acacia Senegal Gum, Phenoxyethanol, Niacinamide, Maltodextrin, Ethylhexylglycerin, Sodium PCA, Xanthan Gum, Tocopheryl Acetate, Syringa Vulgaris (Lilac) Extract, Quartz, Dipotossium Glycyrrhizate, Centella Asiatica Extract, Hibiscus Rosa-Sinensis Flower Extract, Lavandula Angustifolia (Lavender) Extract, Origanum Vulgare Leaf Extract, Thymus Vulgaris (Thyme) Extract

questions?

call 1.800.433.6650 monday - friday 7:30am - 4:30 pm mst

Principal Display Panel – 15 mL Carton Label

bioelements

spot defy™

5% sulfur overnight spot treatment
to clear active acne blemishes

ACNE ACTIVIST

15 mL / .5 fl oz

INGREDIENTS AND APPEARANCE

SPOT DEFY 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Kaolin (UNII: 24H4NWX5CO)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Glycerin (UNII: PDC6A3C0OX)
Butylene Glycol (UNII: 3XUS85K0RA)
Bentonite (UNII: A3N5ZCN45C)
Acacia (UNII: 5C5403N26O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Niacinamide (UNII: 25X51I8RD4)
Maltodextrin (UNII: 7CVR7L4A2D)
Ethylhexylglycerin (UNII: 147D247K3P)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Xanthan Gum (UNII: TTV12P4NEE)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Syringa Vulgaris Flower (UNII: 9V5O040S3W)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Centella Asiatica Whole (UNII: 7M867G6T1U)
Hibiscus Rosa-Sinensis Flower (UNII: VB092Y7Z8T)
Lavandula Angustifolia Whole (UNII: 51217XIL5L)
Oregano (UNII: 0E5AT8T16U)
Thyme (UNII: CW657OBU4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-200-10	1 in 1 CARTON	09/01/2024
1	NDC: 49825-200-20	15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/01/2024

Labeler - Bioelements (174813923)