Label: CELESTY HYPERPIGMENTATION SERIES ULTRA BRIGHTENING GEL CLEANSER- salicylic acid gel

  • 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 10, 2020

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

  • Drug Facts :

  • Active Ingredients

    Salicylic Acid : 1%

  • Purpose

    Acne treatment 

  • Use

    Helps clean and prevent uneven 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 skin irritation develops when using this product.

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

  • Additional Information

    You may experience mild redness, a warm, tingling sensation or flaking (skin exfoliation). These are normal, temporary indications that the formula is working. If effects persist or cause discomfort, limit use to once every 2 to 3 days until skin adjusts, then revert to daily use.

    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. Keep away from fire and flame.

  • Directions

    Lightly lather in hands and apply to damp face and neck morning and evening, massaging upward for at least 30 seconds, avoiding the eye area. Reduce to one use per day if any sensitivity develops. Follow with SPF30 cream when used in the morning.

  • Inactive Ingredients

    Water\Aqua\Eau, Ammonium Laureth Sulfate, Glycolic Acid, Cocamidopropyl Betaine, Potassium Hydroxide, Glycerin, Propylene Glycol, Panthenol (Pro Vitamin B5), Sodium Benzoate, Disodium EDTA, Potassium Sorbate, Benzyl Alcohol, Xanthan Gum, Morus Alba Bark Extract, Arctostaphylos Uva Ursi Leaf Extract, Butylene Glycol, Parfum/Fragrance, Vitamin C (Sodium Ascorbyl Phosphate), Ascorbic Acid.

  • SPL UNCLASSIFIED SECTION

    brighten with HYPERPIGMENTATION series

    SALICYLIC ACID

    UVA-URSI LEAF EXTRACT

    PRO VITAMIN B5

    BEAUTY CARE

    (ALL SKIN TYPES / UNEVEN SKIN)

    Ultra-brightening gel cleanser is formulate to help prevent general skin tone inequalities.

    Uva ursi extract helps regulate the uneven skin tone. Morus Alba Bark Extract helps for radiance.

    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

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    CELESTY  HYPERPIGMENTATION SERIES ULTRA BRIGHTENING GEL CLEANSER
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81120-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81120-112-011 in 1 BOX12/07/2020
    1200 mL in 1 BOTTLE, PLASTIC; 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(81120-112)