Label: SPF 8 LIP MOISTURIZERS- zinc oxide kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 5, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc oxide 4%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn.

  • Warnings

    Skin Cancer/ Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    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 generously before sun exposure and as needed. Children under 6 months of age, ask a doctor. Generously glide over lips and use often.

  • Other Information

    Minimal sun protection product. 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

    Organic plant oils of helianthus annuus (organic sunflower seed oil)1, ricinus communis (organic castor seed oil)1, euphorbia cerifera (candelilla wax), theobroma cacao (organic cocoa seed butter)1, cocos nucifera (organic coconut oil)1, fragaria ananassa (organic strawberry flavor)1, aloe barbadensis (organic aloe oil)1, vaccinium corymbosum (organic blueberry flavor)1, tocopherol (Vitamin E). May contain titanium dioxide, mica, iron oxides.

    1
    certified organic ingredient
  • Questions?

    www.juicebeauty.com

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    juice BEAUTY
    THE ORGANIC SOLUTION™

    SPF 8 Lip Moisturizers
    .15 oz / 4.25 g ea

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    SPF 8 LIP MOISTURIZERS 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55165-0201
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55165-0201-11 in 1 CARTON; Type 0: Not a Combination Product10/10/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 4.25 g
    Part 21 TUBE 4.25 g
    Part 31 TUBE 4.25 g
    Part 1 of 3
    SPF 8 LIP MOISTURIZER JOYFUL 
    zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sunflower Oil (UNII: 3W1JG795YI)  
    Candelilla Wax (UNII: WL0328HX19)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Castor Oil (UNII: D5340Y2I9G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Mica (UNII: V8A1AW0880)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/10/2014
    Part 2 of 3
    SPF 8 LIP MOISTURIZER NATURALLY CLEAR 
    zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sunflower Oil (UNII: 3W1JG795YI)  
    Candelilla Wax (UNII: WL0328HX19)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Castor Oil (UNII: D5340Y2I9G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/10/2014
    Part 3 of 3
    SPF 8 LIP MOISTURIZER PLAYFUL 
    zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sunflower Oil (UNII: 3W1JG795YI)  
    Candelilla Wax (UNII: WL0328HX19)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Castor Oil (UNII: D5340Y2I9G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Mica (UNII: V8A1AW0880)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/10/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/10/2014
    Labeler - Juice Beauty (263151582)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!