Label: SUNSCREEN SPF 30 MEIJER- avobenzone 2% homosalate 5.5% octisalate 4.5% octocrylene 4% 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 June 14, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients                                                               Purpose
    Avobenzone 2%...................................................................Sunscreen
    Homosalate 5.5%.................................................................Sunscreen
    Octisalate 4.5%....................................................................Sunscreen
    Octocrylene 4%.....................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • higher SPF gives more sunburn
    protection• retains SPF after 80 minutes of activity in the water

  • WARNINGS

    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 or irritation develops and lasts

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions • Apply liberally 15 minutes before sun exposure and as
    needed. • Children under 6 months of age: ask a doctor. • Reapply: • after
    80 minutes of swimming or sweating • immediately after towel drying • at
    least every 2 hours. • Sun Protection Measures. Spending time in the
    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, hats,
    and sunglasses. • For sunscreen use: • apply to all skin exposed to the
    sun. • Reapply as needed or after towel drying, swimming, or sweating.

  • OTHER SAFETY INFORMATION

    Other information • protect the product in this container
    from excessive heat and direct sun • may stain fabrics.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate
    Crosspolymer, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii
    (Shea) Butter, Carica Papaya (Papaya) Fruit Extract, Cetearyl Alcohol,
    Ceteth-10 Phosphate, Coco-Glucoside, Colocasia Antiquorum Root
    Extract, Dicetyl Phosphate, Diisopropyl Adipate, Dimethicone, Disodium
    EDTA, Ethylhexyl Benzoate, Fragrance, Glycerin, Jojoba Alcohol,
    Mangifera Indica (Mango) Fruit Extract, Mangifera Indica (Mango) Seed
    Butter, Methylparaben, Mica, Neopentyl Glycol Diheptanoate, Panthenol,
    Paraffin, Passiflora Incarnata Fruit Extract, Phenoxyethanol, Plumeria
    Acutifolia Flower Extract,
    Polymethylsilsesquioxane, Potassium Jojobate,
    Propanediol, Propylene Glycol Dibenzoate,
    Propylparaben, Psidium Guajava Fruit Extract,
    Simmondsia Chinensis (Jojoba) Butter, Sodium
    Ascorbyl Phosphate, Sodium Hydroxide,
    Titanium Dioxide, Tocopheryl Acetate,
    VP/Eicosene Copolymer, Water, Xanthan Gum

  • Questions? 866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 30  MEIJER
    avobenzone 2% homosalate 5.5% octisalate 4.5% octocrylene 4% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-794
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone2 g  in 100 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate5.5 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate4.5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PAPAYA (UNII: KU94FIY6JB)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Ceteth-10 Phosphate (UNII: 4E05O5N49G)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    Diisopropyl Adipate (UNII: P7E6YFV72X)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)  
    Glycerin (UNII: PDC6A3C0OX)  
    MANGO (UNII: I629I3NR86)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Mica (UNII: V8A1AW0880)  
    Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)  
    Panthenol (UNII: WV9CM0O67Z)  
    Paraffin (UNII: I9O0E3H2ZE)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    Propanediol (UNII: 5965N8W85T)  
    Propylene Glycol Dibenzoate (UNII: EQY32Z1AN4)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    GUAVA (UNII: 74O70D6VG0)  
    JOJOBA BUTTER (UNII: XIA46H803R)  
    Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-794-06237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/26/2017
    Labeler - Meijer (006959555)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41250-794) , label(41250-794)