Label: CELESTY OIL CONTROL SERIES MATTIFYING SUNSCREEN SPF 30- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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

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  • Drug Facts:

  • Active Ingredients

    Zinc Oxide (Nano)19,4%

  • 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, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Carbomer, Glyceryl Stearate, Cetyl Alcohol, Sorbitan Stearate, PEG-100 Stearate, Laureth-4, Butylene Glycol, Dimethicone, Polyhydroxystearic Acid, Phenoxyethanol, Xanthan Gum, PEG-8, Polyethylene Glycol, Caprylyl Glycol, Sodium Lactate, Isostearic Acid, Teprenone, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Disodium EDTA, Triethanolamine, Ethylhexylglycerin, Tocopherol (Vitamin E), Sodium Acrylates Copolymer, Lecithin, Imperata Cylindrica Root Extract, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Plankton Extract, [+/- May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499)

  • SPL UNCLASSIFIED SECTION

    restrain with OIL CONTROL series

    ZINC OXIDE

    VITAMIN E

    BEAUTY CARE

    (FOR OILY/COMBINATION SKIN TYPES)

    Mineral and lightweight water-based formula. Specially formulated with zinc oxide. Provides broad-spectrum protection against skin-aging UVA rays.

    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  OIL CONTROL SERIES MATTIFYING SUNSCREEN SPF 30
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81120-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION194 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LAURETH-4 (UNII: 6HQ855798J)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    TEPRENONE (UNII: S8S8451A4O)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ARABIDOPSIS THALIANA WHOLE (UNII: AI3L60HQ81)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81120-108-011 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(81120-108)