Sunday Riley Saturn Sulfur Acne Spot Treatment Mask Cream
FDA Label NDC 73001-305

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sunday Riley Modern Skincare, Llc for the product Sunday Riley Saturn Sulfur Acne Spot Treatment Mask (NDC 73001-305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients

Sulfur 10%

Purpose

Acne treatment

Uses

• For the management of acne

• Penetrates pores to control blackheads

• Helps prevent new acne blemishes and blackheads from forming

Warnings

For external use only.

When using this product

• Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin

• If this occurs, only one medication should be used

• Apply only to areas with acne

Do not use on

• Broken skin

• Large areas of the skin

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Cleanse the skin thoroughly before applying medication.

• For rinse off treatment, apply to dry skin.

• Leave on for 20 minutes and rinse off thoroughly with water.

• For leave-on, overnight treatment, apply to affected area, and rinse off thoroughly in the morning with water.

• Use 2-3 times a week.

• If going outside, use a sunscreen.

• If bothersome dryness or peeling occurs, reduce application use.

Inactive Ingredients

Aqua/Water/Eau, Cetyl Ethyhexanoate, Isoamyl Laurate, Niacinamide, Acacia Senegal Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Bentonite, Leptospermum Scoparium Brach/Leaf Oil, Olive Oil Glycereth-8 Esters, Polyglyceryl-2 Caprate, Zinc PCA, Polysorbate 20, Dipotassium Glycyrrhizate, Allantoin, PEG-40 Hydrogenated Castor Oil, Disodium EDTA, Tocopherols, Denatured Alcohol, Melia Azadirachta Leaf Extract, Amber Powder, Melia Azadirachta Flower Extract, Coccinia Indica Leaf Extract, Ocimum Basilicum (Basil) Flower/leaf Extract, Solanum Melongena (Eggplant) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Corallina Officinalis Extract, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, 4-terpineol.

Packaging

Saturn-1 (73001305 1)

Saturn-1 (73001305 1)

* Please review the disclaimer below.