Label: JERGENS NATURAL GLOW FACE MOISTURIZER MEDIUM TO DEEP SKIN TONES- avobenzone,octisalate, octocrylene 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 June 27, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzone 1.25%

    Octisalate 5%

    Octocrylene 1.1%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Use

    helps prevent sunburn

  • WARNINGS

    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 swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    For sunscreen use:

    • apply generously and evenly to freshly cleansed face, avoiding eyebrows, 15 minutes before sun exposure
    • wash hands after application
    • reapply at least every 2 hours*
    • use a water resistant sunscreen if swimming or sweating
    • children under 6 months of age: 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 sunglasses
  • STORAGE AND HANDLING

    Other information

    protect the product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Dihydroxyacetone, Glycerin, Aluminum Starch Octenylsuccinate, Dicaprylyl Ether, Glyceryl Stearate, Polyacrylamide, Behebyk Alcohol, C12-15 Akyl Benzoate, Dimethicone, Phenyl Trimethicone, PEG-100 Stearate, C13-14 Isoparaffin, Erythrylose, Cetyl Alcohol, Diethylhexyl 2,6 Naphthalate, Steareth-2, Fragrance, Xanthan Gum, Laureth-7, Citric Acid, Fragrance, Tocopheryl Acetate, Zea Mays (Corn) Starch, Methylparaben, Ethylparaben, Propylparaben, Caramel

  • QUESTIONS

    Questions or comments? 1-800-742-8798

  • SPL UNCLASSIFIED SECTION

    How to Use to get Natural-Looking Color: For best results, use daily as your facial moisturizer. Apply a generous amount evenly over freshly cleansed face, blending into jawline & hairline and avoiding eyebrows. Allow several minutes for it to fully absorb. Wash your hands after application. You will begin to see development of color within several days with no sunless tanner odor. If color change is not as noticeable as desired, apply more frequently.

  • SPL UNCLASSIFIED SECTION

    *If reapplying at least every 2 hours for sunscreen use, a non-glow sunscreen is recommended if color change becomes too intense.

    www.jergens.com or call 1-800-742-8798

    Distributed by Kao USA Inc., Cincinnati, OH 45214 ©2021

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    JERGENS®

    NATURAL GLOW

    GRADUALLY CREATES FLAWLESS, NATURAL-LOOKING COLOR WHEN USED ONCE DAILY

    FACE MOISTURIZER

    MEDIUM TO DEEP SKIN TONES

    WITH BROAD SPECTRUM SPF 20 SUNSCREEN

    OIL FREE • CRUELTY FREE

    2 FL OZ (59 mL)

    label

  • INGREDIENTS AND APPEARANCE
    JERGENS NATURAL GLOW FACE  MOISTURIZER MEDIUM TO DEEP SKIN TONES
    avobenzone,octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-718
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.74 g  in 59 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.95 g  in 59 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.65 g  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIHYDROXYACETONE (UNII: O10DDW6JOO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    STEARETH-2 (UNII: V56DFE46J5)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    L-ERYTHRULOSE (UNII: WKK1W5B83O)  
    CARAMEL (UNII: T9D99G2B1R)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-718-201 in 1 BOX06/27/2023
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/27/2023
    Labeler - Kao USA Inc. (004251617)