SPL v5
SPL
SPL Set ID 8d28ec4c-429b-4a2d-8ed5-f572db6c330c
Route
TOPICAL
Published
Effective Date 2014-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (11 g) Zinc Oxide (4 g) Salicylic Acid (2 g)
Inactive Ingredients
Cyclomethicone 5 Cyclomethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Sorbitan Isostearate Tribehenin Calcium Behenate Melanin Synthetic (tyrosine, Peroxide) Dimethiconol (41 Mpa.s) Aluminum Oxide Peg-10 Dimethicone (600 Cst) Methicone (20 Cst) Ferric Oxide Red Cholecalciferol Lycopene Glycerin Sucrose Palmitate Lecithin, Soybean Water Disodium Laureth Sulfosuccinate Sodium Cocoyl Isethionate Sodium Lauroamphoacetate Sodium Methyl Cocoyl Taurate Methylisothiazolinone Cocamidopropyl Betaine .alpha.-bisabolol, (+/-)- Ginger Oat Edetate Disodium Curdlan Eucalyptus Oil Xanthan Gum Menthol Myristoyl Pentapeptide-4 Acetyl Carboxymethyl Cocoyl Glycine Phenoxyethanol Caprylyl Glycol 1,3-butylene Glycol Glycolic Acid Polyquaternium-10 (400 Cps At 2%) Eucalyptus Globulus Leaf Glycyrrhiza Glabra Myristoyl Tetrapeptide-4 Hydroxyphenyl Propamidobenzoic Acid Pentylene Glycol Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-05-10
Description

ACTIVE INGREDIENT SALICYLIC ACID 2%

Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

USE FOR TREATMENT OF ACNE

Dosage and Administration

DIRECTIONS

* USE AM/PM OR AS DIRECTED BY A DOCTOR. APPLY A NICKEL-SIZE AMOUNT TO WET HANDS. RUB TOGETHER. GENTLY MASSAGE ONTO FACE AND NECK WITH CIRCULAR MOTIONS. LEAVE ON 1-2 MINUTES THEN RINSE WELL.

Description

ACTIVE INGREDIENT SALICYLIC ACID 2%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50567-7

WHEN USING THIS PRODUCT * AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. * KEEP AWAY FROM LIPS AND MOUTH.

Section 50568-5

ASK A DOCTOR OR PHARMACIST BEFORE USE IF *PREGNANT OR LACTATING. YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Section 50570-1

DO NOT USE * IF YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO SALICYLIC ACID.

Section 51727-6

INACTIVE INGREDIENTS: WATER, DISODIUM LAURETH SULFOSUCCINATE, SODIUM COCOYL ISETHIONATE, SODIUM LAUROAMPHOACETATE, GLYCERIN, SODIUM METHYL COCOYL TAURATE, METHYLISOTHIAZOLINONE, COCAMIDOPROPYL BETAINE, BISABOLOL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, OAT (AVENA SATIVA) KERNEL EXTRACT, DISODIUM EDTA, BETA GLUCAN, EUCALYPTUS GLOBULUS OIL, XANTHAN GUM, MENTHOL, MYRISTOYL TETRAPEPTIDE-13, ACETYL CARBOXYMETHYL COCOYL GLYCINE, PHENOXYETHANOL, CAPRYLYL GLYCOL.

Section 51945-4

Section 53413-1

QUESTIONS OR COMMENTS?

CALL 877.423.1314 * WWW.LOVEMYBODY.COM

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENT

SALICYLIC ACID 2%

Section 60561-8

OTHER INFORMATION

* AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

Structured Label Content

Indications and Usage (34067-9)

USE FOR TREATMENT OF ACNE

Dosage and Administration (34068-7)

DIRECTIONS

* USE AM/PM OR AS DIRECTED BY A DOCTOR. APPLY A NICKEL-SIZE AMOUNT TO WET HANDS. RUB TOGETHER. GENTLY MASSAGE ONTO FACE AND NECK WITH CIRCULAR MOTIONS. LEAVE ON 1-2 MINUTES THEN RINSE WELL.

Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT * AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. * KEEP AWAY FROM LIPS AND MOUTH.

Section 50568-5 (50568-5)

ASK A DOCTOR OR PHARMACIST BEFORE USE IF *PREGNANT OR LACTATING. YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Section 50570-1 (50570-1)

DO NOT USE * IF YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO SALICYLIC ACID.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: WATER, DISODIUM LAURETH SULFOSUCCINATE, SODIUM COCOYL ISETHIONATE, SODIUM LAUROAMPHOACETATE, GLYCERIN, SODIUM METHYL COCOYL TAURATE, METHYLISOTHIAZOLINONE, COCAMIDOPROPYL BETAINE, BISABOLOL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, OAT (AVENA SATIVA) KERNEL EXTRACT, DISODIUM EDTA, BETA GLUCAN, EUCALYPTUS GLOBULUS OIL, XANTHAN GUM, MENTHOL, MYRISTOYL TETRAPEPTIDE-13, ACETYL CARBOXYMETHYL COCOYL GLYCINE, PHENOXYETHANOL, CAPRYLYL GLYCOL.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

QUESTIONS OR COMMENTS?

CALL 877.423.1314 * WWW.LOVEMYBODY.COM

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

SALICYLIC ACID 2%

Section 60561-8 (60561-8)

OTHER INFORMATION

* AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:48.755498 · Updated: 2026-03-14T22:53:45.950699