SUNDAY RILEY SULFUR ACNE TREATMENT MASK- sulfur cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Sulfur 10%
Available from:
Sunday Riley Modern Skincare, Llc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne treatment - For the management of acne - Penetrates pores to control blackheads - Helps prevent new acne blemishes and blackheads from forming
Authorization status:
OTC monograph final
Authorization number:
73001-340-60

SUNDAY RILEY SULFUR ACNE TREATMENT MASK- sulfur cream

Sunday Riley Modern Skincare, Llc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SUNDAY RILEY SULFUR ACNE TREATMENT MASK

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, Bentonite, Niacinamide, Isoamyl Laurate, Cetyl Ethyhexanoate, Hydroxyethyl

Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Olive Oil Glycereth-8 Esters, Polyglyceryl-2

Caprate, Gum Arabic, Sorbitan Isostearate, Polysorbate 60, Zinc PCA, Leptospermum Scoparium

(Manuca) Brach/Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Dipotassium

Glycyrrhizate, Allantoin, Quartz, Plosorbate 20, PEG-40 Hydrogenated Castor Oil, Disodium

EDTA, Tocopherol, Alcohol Denat., Melia Azadirachta Leaf Extract, Amber Powder, Melia

Azadirachta Flower Extract, Coccinia Indica Fruit Extract, Ocimum Basilicum Flower/Leaf

Extract, Solanum Melongena Leaf Extract, Curcuma Longa Root Extract, Corallina Officinalis

Extract, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin

for acne-prone skin

10% Sulfur + 4% Niacinamide + 1% Zinc

SATURN

Medicated mask dries and clears up acne, while preventing new blemishes from forming

10% sulfur penetrates pores to clear up existing acne while preventing new blemishes from forming.

Treats multiple forms of acne breakouts, including blocked pores, inflammatory acne, hormonal acne

and acne rosacea.

4% niacinamide promotes clear skin, while boosting skin's healthy-looking radiance. Zinc PCA and

bentonite help to clear impurities, reduce excess oil, and soothe the appearance of redness, without

overdrying.

Highly potent tea tree oil, standardized for high levels of terpinen-4-ol, partnered with manuka oil,

purifies the skin, Complexion looks and feels smoother and clearer with each use.

Made in USA of responsibly sourced domestic and foreign ingredients

Dist: Sunday Riley Modern Skincare, LLC

Houston, TX 77027

EU RP: Obelis s.a., 1030 Brussels, Belgium

www.sundayriley.com

Packaging

SUNDAY RILEY SULFUR ACNE TREATMENT MASK

sulfur cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 0 1-340

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

6 g in 6 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BENTO NITE (UNII: A3N5ZCN45C)

NIACINAMIDE (UNII: 25X51I8 RD4)

ISO AMYL LAURATE (UNII: M1SLX0 0 M3M)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

HYDRO XYETHYL ACRYLATE/SO DIUM ACRYLO YLDIMETHYL TAURATE CO PO LYMER ( 10 0 0 0 0 MPA.S AT

1.5%) (UNII: 8 6 FQE9 6 TZ4)

O LIVE O IL GLYCERETH-8 ESTERS (UNII: 322K2STO13)

PO LYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)

ACACIA (UNII: 5C540 3N26 O)

SO RBITAN ISO STEARATE (UNII: 0 1S2G2C1E4)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

ZINC PIDO LATE (UNII: C32PQ8 6 DH4)

MANUKA O IL (UNII: M6 QU9 ZUH2X)

4 -TERPINEO L, ( +/-) - (UNII: L6 5MV77ZG6 )

GLYCYRRHIZINATE DIPO TASSIUM (UNII: CA2Y0 FE3FX)

ALLANTO IN (UNII: 344S277G0 Z)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

AZADIRACHTA INDICA LEAF (UNII: HKY9 1578 0 T)

AMBER (UNII: 70 J9 Z0 J26 P)

AZADIRACHTA INDICA FLO WER (UNII: 3TE8 A9 2UPM)

CO CCINIA GRANDIS FRUIT (UNII: VLJ6 WOT3K5)

Sunday Riley Modern Skincare, Llc

O CIMUM BASILICUM FLO WERING TO P (UNII: 7SAB275FP2)

EGGPLANT (UNII: W5K7RAS4VK)

TURMERIC (UNII: 8 56 YO1Z6 4F)

CO RALLINA O FFICINALIS (UNII: 40 0 449 8 D0 6 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 0 1-340 -6 0

1 in 1 BOX

0 1/0 8 /20 17

1

6 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333D

0 1/0 8 /20 17

Labeler -

Sunday Riley Modern Skincare, Llc (012302640)

Revised: 4/2019

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