Label: SUNSCREEN SPF 50 cream

  • NDC Code(s): 84148-002-01
  • Packager: Guangzhou Ariel Biotech Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 28, 2024

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS :

    ACTIVE INGREDIENTSPURPOSEOCTOCRYLENE8%…………Sunscreen

    ETHYLHEXYL SALICYLATE 5%.…………Sunscreen

    ZINC OXIDE 3%.....Sunscreen

  • DESCRIPTION

    Use:

    Helps prevent sunburn

  • WARNINGS

    Warnings:

    WARNINGSFor external use only.Store at room temperatureDiscontinue use if redness or irritation occurs

  • DO NOT USE

    DO NOT USE
    on damaged or broken skin

  • WHEN USING

    WHEN USING SECTION:

    When using this product, avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

    Discontinue use if any irritation or adverse reaction occurs.

  • INSTRUCTIONS FOR USE

    WHEN USING SECTION
    When using this product, avoid contact with eyes. lf contact occursrinse thoroughly with water.
    Discontinue use if any irritation or adverse reaction occurs

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS
    1,2-HEXANEDIOL, AMINOMETHYL PROPANOL, AQUA, ARACHIDYL ALCOHOLARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BETAINE, BUTYLMETHOXYDIBENZOYLMETHANE, BUTYLENE GLYCOL, CENTELLA ASIATICAEXTRACT, CETEARYL ALCOHOL, CETYL PHOSPHATE, CYCLOHEXASILOXANECYCLOPENTASILOXANE, DISODIUM EDTA, ECTOIN, GLUCOSE, GLYCERIN,GLYCERYL POLYACRYLATE, HYDROXYACETOPHENONE, HYDROXYETHYLACRYLATE / SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, JASMINUMSAMBAC (JASMINE) FLOWER EXTRACT, NEOPENTYL GLYCOL DIHEPTANOATENIACINAMIDE, PHENYLBENZIMIDAZOLE SULFONIC ACID, POLYACRYLATE-13.POLYISOBUTENE, POLYSILICONE-11, POLYSORBATE 20, POLYSORBATE 60.PROPANEDIOL, SAURURUS CHINENSIS LEAF/ROOT EXTRACT, SORBITANISOSTEARATE, STEPHANIA TETRANDRA EXTRACT, TARAXACUM OFFICINALE(DANDELION) LEAF EXTRACT, XANTHAN GUM.

  • OTHER SAFETY INFORMATION

    Manufactured by Guangzhou Ariel Biotech Co., Ltd

    No. 79 Ruihe Road, Huangpu District, Guangzhou,Guangdong, China

  • PURPOSE

    Sunscreen

  • DOSAGE & ADMINISTRATION

    DIRECTIONS
    1.Squeeze an appropriate amount of sunscreen into the palm of yourhand and spread it evenly on the face. Don't forget that sunscreen isalso required on the neck and ears.2. Wait 5-10 minutes for the sunscreen to absorb fully.3. For outdoor activities, sunscreen must be reapplied every 2-3hours or after swimming or sweating.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    WHEN USING SECTION
    When using this product, avoid contact with eyes. lf contact occurs.
    rinse thoroughly with water.
    Discontinue use if any irritation or adverse reaction occurs

  • PRINCIPAL DISPLAY PANEL

    84148-002-01

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 50 
    sunscreen spf 50 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84148-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ECTOINE (UNII: 7GXZ3858RY)  
    TARAXACUM OFFICINALE (UNII: 39981FM375)  
    BETAZINE (UNII: AIK06F3ZZY)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    ENSULIZOLE (UNII: 9YQ9DI1W42)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CYCLOMETHICONE 7 (UNII: KCK5L8VU47)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    POLYACRYLATE-13 (UNII: FS2D4T67EA)  
    STEPHANIA TETRANDRA WHOLE (UNII: 7S7TV2F4XC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    SAURURUS CHINENSIS FLOWER (UNII: 9L0SCP0SKZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84148-002-0150 g in 1 BOTTLE; Type 0: Not a Combination Product03/28/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/12/2024
    Labeler - Guangzhou Ariel Biotech Co., Ltd. (402818771)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU ARIEL BIOTECH CO., LTD402818771manufacture(84148-002)
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