Label: ECO LIPS ZINC SPF 30 BROAD SPECTRUM SUNSCREEN UNSCENTED- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 22, 2023

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  • Active Ingredient

    Active Ingredient: Zinc Oxide - 15.7% (non-nanoparticle)

  • Purpose

    Purpose Sunscreen

  • Uses

    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

    Warnings For external use only

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

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

  • Directions

    Directions

    •Apply liberally 15 minutes before sun exposure.

    • Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours.

    • Children under six months: Ask a doctor.
    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 sun glasses.

  • Inactive Ingredients

    Inactive ingredients Aloe Barbadensis Leaf *, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Microcrystalline Cellulose, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol, Water.

    *Indicates Certified Organic

  • OTHER SAFETY INFORMATION

    Other information Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    Questions or comments?

    1-866-326-5477

  • SPL UNCLASSIFIED SECTION

    ECO

    LIPS

    ZINC

    SPF 30

    BROAD SPECTRUM SPF 30

    SUNSCREEN LOTION

    UNSCENTED

    NON-GREASY

    WATER RESISTANT

    (80 MINUTES)

    Moisturizer with Aloe,

    Shea Butter, and Cocoa Butter.

    OXYBENZONE FREE

    MANUFACTURED FOR

    ECO LIPS, INC.

    CEDAR RAPIDS, IA 52402

    ECOLIPS.COM

  • PRINCIPAL DISPLAY PANEL

    Tube

  • INGREDIENTS AND APPEARANCE
    ECO LIPS ZINC SPF 30 BROAD SPECTRUM SUNSCREEN UNSCENTED 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75071-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75071-415-07118.3 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02006/01/2023
    Labeler - Eco Lips, Inc. (138732727)