Spot Defy

Manufacturer
Bioelements, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:33:56

Label at a glance#

ProductSpot Defy
Active ingredientSULFUR
Label structure8 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

active ingredient

OTC - ACTIVE INGREDIENT SECTION

sulfur 5%

purpose

OTC - PURPOSE SECTION

acne treatment

indications

INDICATIONS & USAGE SECTION

clears acne pimples

warnings

WARNINGS SECTION

for external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children.

OTC - WHEN USING SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

when using this product apply only to areas with acne.

directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Principal Display Panel – 15 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bioelements

spot defy™

5% sulfur overnight spot treatment
to clear active acne blemishes

ACNE ACTIVIST

15 mL / .5 fl oz

Principal Display Panel – 15 mL Carton Label
Principal Display Panel – 15 mL Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
422938sulfur 5 % Topical LotionPSN3
422938sulfur 50 MG/ML Topical LotionSCD3
422938sulfur 5 % Topical LotionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-200-10Spot Defy1 in 1 CARTONLOTION13
49825-200-20Spot Defy15 mL in 1 BOTTLE, GLASSLOTION153

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49825-20049825-200-20, 49825-200-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spot DefySULFURBioelements, Inc.6f35f950-8d04-4181-a897-5679fde1e2d92025-12-17WarningsExact identifier
ndc (package): 49825-200-20
ndc (package): 49825-200-10
ndc (product): 49825-200
ndc11 (package): 49825020020
ndc11 (package): 49825020010
spl id: 462acf75-cc59-2738-e063-6294a90a47de
spl set id: 6f35f950-8d04-4181-a897-5679fde1e2d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.