Label: CELESTY ACNE SERIES INSTANT REPAIR MASK- sulfur cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 8, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts:

  • Active Ingredients

    Sulfur : 3%

  • Purpose

    Acne treatment

  • Use

    Treatment mask for acne prone skin.

  • Warnings

    For external use only. Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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

  • Other Information

    Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen and limit sun exposure while using this product. Store at room temperature.

  • How to use

    • Apply once or twice a week to clean skin as a thin layer. • Wait 20 minutes and rinse with water. • For optimal results, follow with a suitable moisturizer.

  • Inactive Ingredients

    Water\Aqua\Eau, Bentonite, PEG-30 Castor Oil, Talc, Kaolin, Propylene Glycol, Acaccia Senegal Gum, Glycerin, Titanium Dioxide (Cl 77891), Zinc Oxide, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, PVP, Aloe Barbadensis Leaf Juice, Allantoin, Sodium PCA, Disodium EDTA, Citric Acid.

  • SPL UNCLASSIFIED SECTION

    clarify with ACNE series

    1-2 / WEEK

    SULFUR

    ZINC

    BENTONITE CLAY 

    SODIUM PCA

    BEAUTY CARE

    Brace Beauty, Embrace Purity.

    www.celesty.com

    Made in TURKEY

    MABA KOZMETIK A.S.

    ESENTEPE MAH. YUZBASI KAYA ALDOGAN SOK.

    ONUR IS MERKEZI NO:12 D:8 ISTANBUL

    Distributed by CELESTY LLC

    3970 NW 167TH ST. MIAMI GARDENS,

    FL 33054 - USA

    info@celesty.com

    (FOR ACNE PRONE SKIN)

    It is a keratolytic treatment mask formulated for acne treatment. This powerful mask helps block excessive oil release. Contains skin restoratives like Sulfur, Zinc, Bentonite, Allantoin, Aloe vera. Draws out the impurities deep in your skin, providing a powerful detox effect. Helps minimize the pores.

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    CELESTY  ACNE SERIES INSTANT REPAIR MASK
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81120-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENTONITE (UNII: A3N5ZCN45C)  
    PEG-30 CASTOR OIL (UNII: GF873K38RZ)  
    TALC (UNII: 7SEV7J4R1U)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ACACIA (UNII: 5C5403N26O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81120-103-011 in 1 BOX12/07/2020
    1120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/07/2020
    Labeler - MABA KOZMETIK LIMITED SIRKETI (503001418)
    Establishment
    NameAddressID/FEIBusiness Operations
    MABA KOZMETIK LIMITED SIRKETI503001418manufacture(81120-103)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!