Label: CYBERDERM EVERY MORNING SUN WHIP- zinc oxide, octinoxate lotion

  • NDC Code(s): 71644-004-50, 71644-004-80
  • Packager: Cyberderm Laboratories Inc.
  • 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 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Octinoxate (encapsulated) 7.5%

    Zinc oxide* 15%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    Helps prevent sunburn

  • WARNINGS

    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

    Do not use on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally to face and body 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 of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
  • INACTIVE INGREDIENT

    Inactive ingredients water/eau, caprylic/capric triglyceride*, glyceryl isostearate*, polyhydroxystearic acid*, glyceryl stearate*, PEG-75 stearate, ceteth-20, steareth-20, glycerin*, cetyl dimethicone, methylcellulose, trisodium ethylenediame disuccinate, xanthan gum, sclerotium gum, caprylhydroxamic acid, caprylyl glycol, silica, PVP, chlorphenesin, cetyl alcohol, sodium citrate, phenoxyethanol, disodium EDTA, BHT

  • QUESTIONS

    Questions or comments?

    781-481-2628 Monday - Friday 9 am - 5 pm

  • SPL UNCLASSIFIED SECTION

    *Denotes ingredients that are Ecocert® certified organic.

    Distributed by:

    CyberDERM Laboratories Incorporated

    650-1600 Carling Avenue

    Ottawa, ON K1Z 1G3 Canada

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    cyberderm

    made with love by the sunscreen company™

    Every Morning Sun Whip™ SPF 25

    Transparent sunscreen lotion

    made with 15% zinc oxide and 7.5% encapsulated octinoxate

    SPF 25 Sunscreen

    helps prevent sunburn

    50 mL (1.7 fl oz)

    EM - Box FDA 2018-4-5

  • INGREDIENTS AND APPEARANCE
    CYBERDERM  EVERY MORNING SUN WHIP
    zinc oxide, octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71644-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71644-004-501 in 1 CARTON03/30/2018
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:71644-004-801 in 1 CARTON03/30/2018
    280 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/30/2018
    Labeler - Cyberderm Laboratories Inc. (242524267)
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