Label: SKIN TINTED SUNSCREEN MAKEUP PRIMER SPF 30, BEIGE- avobenzone, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 84102-001-00
  • Packager: Shanghai Chuanyue Biotechnology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 30, 2024

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

  • Drug Facts

  • Active ingredients

    Avobenzone 3%
    Homosalate 10%
    Octisalate 5%
    Octocrylene 7.5%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agingcaused by the sun
  • Warnings

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor

    if rash occurs.

    Keep out of reach of children.

    If swallowed, call a Poison Control Center or get medical help right away

  • Directions

    • Apply liberally/generously (and evenly) 15 minutes before sun exposure.
    • Reapply:
    • at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating.
    • immediately after towel drying
    • Sun Protection Measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2p.m.
    • wear long-sleeved shirts, pants,hats,and sunglasses.
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    Water, Diisopropyl Sebacate, Glycerin, Isodecyl NeopentanOate,Butyloctyl Salicylate,Bismuth Oxychloride, Isododecane,c12-13 Alkyl Lactate, Glyceryl Stearate,Brassica Campestris/Aleurites Fordi Oil Copolymer, Saccharomyces Ferment,Stearyl Glycyrrhetinate,Helianthus Annuus (Sunflower) Seed Oil,Butyrospermum Parkii (Shea) Butter,Ethylhexyl Hydroxystearate,Panthenol,Propanediol,Dipropylene Glycol,Peg-100 Stearate, Cetearyl Glucoside, Camellia Sinensis Seed Oil, Squalane,Sodium Stearoyl Glutamate, Cetaryl Alcohol,Dictamnus Dasycarpus Root Bark Extract,Sorbitan Olivate,Tocopherol,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Arginine,Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer,Candida Bombicola/Glucose/Methyl Rapeseedate Ferment, Alteromonas Ferment Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Butylene Glycol,camellia Sinensis Leaf Extract,citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Limon (Lemon) Fruit Extract,Juniperus Chinensis Xylem Extract, Polyquaternium-61, citrus Aurantium Bergamia (Bergamot) Fruit Oil,Juniperus Virginiana Oil,Citrus Sinensis Extract,Cananga Odorata Flower Oil,Styrax Benzoin Extract,Michelia Alba Leaf Oil, Allantoin, Disodium Edta,Xanthan Gum, Triethoxycaprylylsilane, Hydroxyacetophenone, 1,2-Hexanediol,Caprylyl Glycol,Iron Oxides.

  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Questions?

    Call AP Specialties

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SKIN TINTED SUNSCREEN MAKEUP PRIMER SPF 30, BEIGE 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84102-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    ISODODECANE (UNII: A8289P68Y2)  
    C12-13 ALKYL LACTATE (UNII: 9GLX7JL13M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ARGININE (UNII: 94ZLA3W45F)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MANDARIN OIL (UNII: NJO720F72R)  
    LEMON (UNII: 24RS0A988O)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    YLANG-YLANG OIL (UNII: 8YOY78GNNX)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84102-001-001 in 1 CARTON09/01/2024
    11 in 1 BOX
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2024
    Labeler - Shanghai Chuanyue Biotechnology Co., Ltd. (841882128)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuanyue Biotechnology Co., Ltd.841882128manufacture(84102-001)