Label: OLIVIA AND ALLISON AQUA SKIN SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 84122-050-01, 84122-050-02
  • Packager: Makeup S.he, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 15, 2024

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

  • Active ingredients

    Avobenzone 3.0%

    Homosalate 7.3%

    Octisalate 5.0%

    Octocrylene 8.7%

  • Purpose

    sunscreen

  • Uses

    ■ helps prevent sunburn ■ higher SPF gives more sunburn protection

    ■ if used as directed with other sun protection measures ( see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    For external use only

  • Do not use on

    damaged or broken skin.

  • When using the product

    keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor

    if rash occurs.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    If products is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ apply liberally 15 minutes before sun exposure. 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 ■ children under 6 months of age: Ask a doctor ■ reapply at least every 2 hours. ■ use a water-resistant sunscreen if swimming or sweating.

  • Other information

    ■ protect the product in this container from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

  • Inactive ingredients

    Water, Butyloctyl Salicylate, Cetearyl Alcohol, Poly C10-30 Alkyl Acrylate, Dicaprylyl Carbonate, Cetearyl Glucoside, Niacinamide, Dipropylene Glycol, Sorbitan Olivate, Polymethylsilsesquioxane, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Arginine, Carbomer, Butylene Glycol, Hydroxypropyl Methylcellulose Stearoxy Ether, Tocopheryl Acetate, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Adenosine, Bambusa Vulgaris Leaf Extract, Oldenlandia Diffusa Extract, Lonicera Caprifolium (Honeysuckle) Extract, Yeast Extract, Limonia Acidissima Extract, 1,2-Hexanediol, Glycerin, Tocopherol, Ethyl Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Asiatic Acid, Fragrance, Geraniol, Butylphenyl Methylpropional, Linalool, Benzyl Benzoate, Hexyl Cinnamal, Limonene

  • PRINCIPAL DISPLAY PANEL

    MAKEUPSHE_Aaua skin sunscreen

  • INGREDIENTS AND APPEARANCE
    OLIVIA AND ALLISON AQUA SKIN SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84122-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.35 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.65 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ASIATICOSIDE (UNII: PKO39VY215)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ETHOHEXADIOL (UNII: M9JGK7U88V)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GERANIOL (UNII: L837108USY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BAMBUSA VULGARIS LEAF (UNII: EMY54R518C)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ASIATIC ACID (UNII: 9PA5A687X5)  
    WATER (UNII: 059QF0KO0R)  
    MADECASSIC ACID (UNII: M7O1N24J82)  
    SCLEROMITRION DIFFUSUM (UNII: 291PPU5K9I)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ADENOSINE (UNII: K72T3FS567)  
    YEAST (UNII: 3NY3SM6B8U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ARGININE (UNII: 94ZLA3W45F)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84122-050-021 in 1 BOX02/26/2024
    1NDC:84122-050-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/26/2024
    Labeler - Makeup S.he, Inc. (005613587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebom Co., Ltd.695951708manufacture(84122-050)