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Beauty Without Cruelty - Broad Spectrum SPF 18 (Lotus Brands, Inc.)

Available Formats

Dosage Form Package Information Links
LOTION 118 mL in 1 BOTTLE, PLASTIC (76328-333-01) Label Information

Complete Beauty Without Cruelty - Broad Spectrum SPF 18 Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts:


  • Active ingredient

    Octisalate 5.0%
    Avobenzone 2.5%
    Octocrylene 5.0%


  • 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 aging caused by the 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 product is swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    • apply liberally 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 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: Ask a doctor

  • Inactive ingredients

    Purified water, glycerin, Helianthus annuus (sunflower) seed oil1, Aloe barbadensis (aloe vera) leaf juice1, glyceryl stearate, ethyl hexyl palmitate, stearic acid, glyceryl monolaurate, magnesium ascorbyl phosphate, cetearyl alcohol, tocopherol acetate, tocopherols, Butyrospermum parkii (shea) butter, Macrocystis pyrifera (kelp) extract, squalane2, allantoin, panthenol, Anthemis nobilis (chamomile) extract1, Calendula officinalis (calendula) extract1, hyaluronic acid, sodium carbomer, Lavandula angustifolia (lavender) extract1, Arnica montana (arnica) extract1, Camellia sinensis (white tea) extract1, Rosa canina (rose hip) oil1, Linum usitatissimum (flax) seed oil1, Borago officinalis (borage) seed oil1, lecithin, Cocos nucifera (coconut) oil, phenoxyethanol, ethyl hexyl glycerin.


    1
    • organic
    2
    • Vegetable Source
    18% Organic Content

  • Other information

    • Protect this product from excessive heat and direct sun.

  • Questions or comments?

    Call toll free 1.800.824.6396 M-F 9-5 Central Time excluding weekends & holidays


  • SPL UNCLASSIFIED SECTION

    Distributed by: Lotus Brands, Inc. 1100 Lotus Drive, Silver Lake, WI 53170 USA


  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

    BWC
    BEAUTY WITHOUT CRUELTY®

    fragrance free

    daily
    facial lotion

    broad spectrum
    spf 18 sunscreen

    benefits all skin types

    provides
    uva and uvb protection


    • 100% Vegan—No Animal Ingredients
    • No Animal Testing
    • Aloe vera, Rosehips & Shea Butter
      moisturize, replenish & smooth skin
    • May be used under makeup, alone
      or with your regular moisturizer

    4 fl oz
    118 ml e

    Principal Display Panel - 118 ml Bottle Label

  • INGREDIENTS AND APPEARANCE
    BEAUTY WITHOUT CRUELTY - BROAD SPECTRUM SPF 18 
    octisalate, avobenzone, and octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76328-333
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    SQUALANE (UNII: GW89575KF9)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    BORAGE OIL (UNII: F8XAG1755S)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76328-333-01 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 06/01/2013
    Labeler - Lotus Brands, Inc. (879022713)
    Registrant - Sun Deep Inc. (189788201)
    Establishment
    Name Address ID/FEI Business Operations
    Sun Deep Inc. 189788201 MANUFACTURE(76328-333)