Label: EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30- avobenzone, octinoxate, octisalate, oxybenzone lotion

  • 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 November 29, 2018

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

View All Sections
  • Active ingredients

    Active ingredients                                Purpose
    Avobenzone 3.0%
    Octinoxate 7.5%Sunscreen      }        Sunscreen
    Octisalate 5.0%
    Oxybenzone 4.0%

  • 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

    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:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • 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 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-sleeve shirts, pants, hats, and sunglasses.

  • Inactive ingredients

    Water (Aqua), Glyceryl Stearate, Ethylhexyl Methoxycrylene, Glycerin, Jojoba Esters, Dimethicone, VP/Eicosene Copolymer, Cetearyl Alcohol, Cetyl Dimethicone, Potassium Cetyl Phosphate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Tocopheryl Acetate, Tertrahexyldecyl Ascorbate, Sodium Hyaluronate, Hydroxyethylcellulose, Hexylene Glycol, Punica Granatum Quillaja (Pomegranate) Extract, Cocos Nucifera (Coconut) Extract, Hedychium Coronarium Root (White Ginger) Extract, Actinidia Chinensis (Kiwi Fruit) Extract, Hibiscus Rosa Sinensis Extract, Passion Flora Incarnata (Passion Flower) Extract, Plantago Major Leaf (Plantain) Extract, Saponaria Bark (Soap Bark) Extract

  • Other information

    • protect this product from excessive heat and direct sun

  • Questions or comments?

    Call toll free 1-888-637-5724

  • Purpose

    Sunscreen

  • Description

    EXTRASHADE SUN  PROTECTION FOR RICH COMPLEXIONS BROAD SPECTRUM SPF 30

  • PRINCIPAL DISPLAY PANEL

    EXTRASHADE SUN PROTECTION FOR RICH COMPLEXIONS  BROAD SPECTRUM SPF 30  DAILY DEFENSE HYDRATING SUNSCREEN LOTION  WATER RESISTANT (80 MINUTES) • PABA FREE  FRAGRANCE FREE • OIL FREE • DYE FREE  FACE AND BODY  PROTECTION FOR ACTIVE LIFESTYLE  4.0 Fl Oz (120ml)

  • PRINCIPAL DISPLAY PANEL

    Drug Facts

  • Extra Shade 1

    image description

  • Extra Shade 2

    image description

  • INGREDIENTS AND APPEARANCE
    EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 
    avobenzone, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42338-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COCONUT (UNII: 3RT3536DHY)  
    HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    HIBISCUS ROSA-SINENSIS FLOWERING TOP (UNII: X9SED65819)  
    PASSIFLORA EDULIS FLOWER (UNII: SY49TH8VUA)  
    PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)  
    SAPONARIA OFFICINALIS ROOT (UNII: RI2K1BMA8B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42338-001-041 in 1 CARTON01/06/2012
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/06/2012
    Labeler - Extrashade a Sub of Versitile Group (078350581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Columbia Cosmetics Manufacturing, Inc.068267863manufacture(42338-001)
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!