Label: CELESTY SENSITIVE SKIN SERIES SUNSCREEN SPF30- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 14, 2020

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  • Drug Facts: 

  • Active Ingredients

    Zinc Oxide: 19,5%

  • Purpose

    Sunscreen

  • Use

    Helps prevent sunburn. 

  • 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 rash occurs, 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.

  • Directions

    • Apply minimum 30 minutes before sun exposure. • Repeat every 4 hours • Reapply after swimming or sweating.

  • Other Information

    Protect this product from excessive heat and direct sun. May stain some fabrics.

  • Inactive Ingredients

    Water\Aqua\Eau, C12-15 Alkyl Benzoate, Glycerin, Butylene Glycol, Propanediol, Mirabilis Jalapa Flower/Leaf/Stem Extract, Niacinamide, Dimethicone, Panthenol (Pro Vitamin B5), PEG-100 Stearate, Polyethylene, Cetearyl Glucoside, Pentylene Glycol, Polyhydroxystearic acid, Phenoxyethanol, Squalane, Tocopheryl Acetate (Vitamin E), Cetyl Alcohol, Stearyl Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Benzyl Alcohol, Butyrospermum Parkii (Shea Butter), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citric Acid, Caprylyl Glycol, Sodium Hyaluronate, Retinyl Palmitate (Vitamin A), Carbomer, Disodium EDTA, Hydroxyethylcellulose, Ethylhexylglycerin, Euterpe Oleracea Fruit Extract, Isostearic Acid, Vitis Vinifera (Grape) Seed Extract.

  • SPL UNCLASSIFIED SECTION

    soothe with SENSITIVE SKIN series

    ZINC OXIDE

    NIACINAMIDE

    VITAMIN E

    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 SENSITIVE SKIN)

    Protects sensitive skin against UVA rays and acts against free radical damage that may occur because of sun rays.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    CELESTY  SENSITIVE SKIN SERIES SUNSCREEN SPF30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81120-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION195 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MIRABILIS JALAPA FLOWERING TOP (UNII: 623IWX4U2M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACAI (UNII: 46AM2VJ0AW)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81120-111-011 in 1 BOX12/07/2020
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/07/2020
    Labeler - MABA KOZMETIK LIMITED SIRKETI (503001418)
    Establishment
    NameAddressID/FEIBusiness Operations
    MABA KOZMETIK LIMITED SIRKETI503001418manufacture(81120-111)
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