Label: MILANI PRIME PROTECT SPF 30 FACE PRIMER- avobenzone, octinoxate, octocrylene, and oxybenzone cream

  • NDC Code(s): 71435-8202-6
  • Packager: The Milani Group, Inc.
  • 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 November 3, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone 3.0%Sunscreen
    Octinoxate 7.3%Sunscreen
    Octocrylene 3.0%Sunscreen
    Oxybenzone 2.0%Sunscreen
  • Uses

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

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

    For Sunscreen use:

    • Apply generously and evenly 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in sun increases 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. – 2 p.m.
      • Wear long-sleeved shirts, pants, and sun glasses
      • Children under 6 months of age: Ask a doctor.
  • Other information

    • Protect the product in this container from excessive heat and direct sun
  • Inactive Ingredients

    water, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, PEG-8, phenoxyethanol, polysorbate 80, xanthan gum, tocopherol, ethylhexylglycerin, citric acid, retinyl palmitate, disodium EDTA, glycine soja (soybean) oil, yellow 5 (CI 19140), red 40 (CI 16035).

  • Questions or comments?

    Call 866–789–8002 Monday – Friday (8 a.m. to 5 p.m. PST)

  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

    MILANI

    PRIME
    PROTECT

    SPF 30 FACE PRIMER

    BROAD SPECTRUM SUNSCREEN
    + UVA/UVB PROTECTION

    1 FL OZ / 30 mL

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    MILANI PRIME PROTECT SPF 30 FACE PRIMER 
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71435-8202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE73 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71435-8202-61 in 1 CARTON11/25/2017
    130 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 finalpart35211/25/2017
    Labeler - The Milani Group, Inc. (120923342)
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