SPOTLESS ACNE CLEARING TREATMENT- benzoyl peroxide lotion

SPOTLESS Acne Clearing Treatment by

Drug Labeling and Warnings

SPOTLESS Acne Clearing Treatment by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Uses

For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.

Warnings

For external use only

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.

Stop and ask a doctor

• If skin irritation becomes severe.

Do not use if you

• Have very sensitive skin.
• Are sensitive to benzoyl peroxide.

When using this product

• Avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with the eyes, lips, and mouth.
• Avoid contact with hair and dyed fabrics, which may be bleached by this product.
• Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

• Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

• Clean the skin thoroughly before applying this product.
• Dispense 1-2 pumps and cover the entire affected area with a thin even layer one to three times daily. Do not rinse product off face.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
• Wash hands after application to help avoid staining fabrics.

Other Information

Store between 15-30°C (59-86°F). This product may bleach hair or dyed fabrics.

Inactive Ingredients

Water, Glycereth-18 Ethylhexanoate, Glycereth-18, Glycerin, Butylene Glycol, Vaccinium Angustifolium (Blueberry) Fruit Extract, Sodium Hyaluronate, Polygonum Cuspidatum Root Extract, Bisabolol, Allantoin, Zingiber Officinale (Ginger) Root Extract, Octenidine HCL, Fragrance, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Methyl Methacrylate Crosspolymer, Myristyl Alcohol, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Cyclopentasiloxane, Butyl Hydroxycyclohexane Carboxylate, Dimethyl lsosorbide, Carbomer, Polyglyceryl-2 lsostearate, Sorbitan Oleate, Diethylhexyl Sodium Sulfosuccinate, Cetyl Hydroxyethylcellulose, Cyclohexasiloxane, Polysorbate 80, Xanthan Gum, Hydroxyphenyl Propamidobenzoic Acid, Ascorbyl PaImitate, Tocopherol, PCA, Sodium Citrate, Citric Acid, Sodium Hydroxide, Propanediol, Pentylene Glycol, lsohexadecane, Caprylyl Glycol, 1,2-Hexanediol, Decylene Glycol, Hydroxyacetophenone, Propylene Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Citral, Citronellol, Limonene, Linalool, Titanium Dioxide (Cl 77891), Mica, Tin Oxide, Blue 1 (Cl 42090), Red 33 (Cl 17200), Violet 2 (Cl 60725)

Questions

1-888-995-5656

Principal Display Panel - 50 mL Carton Label

RODAN+FIELDS

SPOTLESS

ACNE
CLEARING
TREATMENT

2

50 mL/1.7 Fl. Oz. U.S.

Principal Display Panel - 50 mL Tube Label

RODAN+FIELDS

SPOTLESS

ACNE
CLEARING
TREATMENT

2

INGREDIENTS AND APPEARANCE

SPOTLESS ACNE CLEARING TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-1620
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	0.025 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)
GLYCERETH-18 (UNII: SA5E43C17C)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GINGER (UNII: C5529G5JPQ)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
ISOHEXADECANE (UNII: 918X1OUF1E)
LEVOMENOL (UNII: 24WE03BX2T)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)
MICA (UNII: V8A1AW0880)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
OCTENIDINE HYDROCHLORIDE (UNII: U84956NU4B)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
PIDOLIC ACID (UNII: SZB83O1W42)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-1620-1	1 in 1 CARTON	02/13/2019
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/13/2019

Labeler - Rodan & Fields (051659584)