Label: ALOE SOOTHING MOISTURE SPF 15- octisalate, avobenzone, octinoxate, and octocrylene lotion

  • NDC Code(s): 57691-889-50
  • Packager: Buth-Na-Bodhaige, 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 October 10, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    Avobenzone (3.0% w/w) Sunscreen
    Octinoxate (2.9% w/w) Sunscreen
    Octisalate (5.0% w/w) Sunscreen
    Octocrylene (2.2% w/w) Sunscreen
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  • Uses

    • helps prevent sunburn.
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  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

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  • 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 sun especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses.
      • reapply this product at least every 2 hours.
      • use a water resistant sunscreen if swimming or sweating.
    • children under 6 months of age: ask a doctor.
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  • Other information

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

    Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Sorbitol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Sesamum Indicum (Sesame) Seed Oil, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Panthenol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Carbomer, Bisabolol, Potassium Sorbate, Tetrasodium EDTA, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pentylene Glycol, BHT, Avena Sativa (Oat) Kernel Extract, Citric Acid.

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  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Label

    THE
    BODY
    SHOP

    THE BODY SHOP
    ALOE

    SOOTHING MOISTURE LOTION

    BROAD SPECTRUM SPF 15 SUNSCREEN

    FRAGRANCE-FREE, COLOURANT-FREE,
    PARABEN-FREE, ALCOHOL-FREE
    WITH PURE, HAND-FILLETED ALOE FROM CAMPECHE, MEXICO

    50 ml (1.69 US FL OZ)

    FORMULATED FOR
    SENSITIVE SKIN

    PRINCIPAL DISPLAY PANEL - 50 ml Tube Label
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  • INGREDIENTS AND APPEARANCE
    ALOE SOOTHING MOISTURE SPF 15 
    octisalate, avobenzone, octinoxate, and octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57691-889
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.029 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.022 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Sorbitol (UNII: 506T60A25R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Panthenol (UNII: WV9CM0O67Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    OAT (UNII: Z6J799EAJK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57691-889-50 50 mL in 1 TUBE; Type 0: Not a Combination Product 04/11/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 04/11/2016
    Labeler - Buth-Na-Bodhaige, Inc., (791071279)
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