Label: SUNSCREEN- sunscreen, zinc oxide lotion

  • NDC Code(s): 83748-001-01
  • Packager: NATURAL AND ORGANIC FORMULATIONS (PTY) LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    30mL Sunscreen Label Drug Facts Active Ingredient Section

  • KEEP OUT OF REACH OF CHILDREN

    30mL Sunscreen Label Drug Facts Children Section

  • PURPOSE

    30mL Sunscreen Label Drug Facts Purpose Section

  • DOSAGE & ADMINISTRATION

    30mL Sunscreen Label Drug Facts Directions Section30mL Sunscreen Label Drug Facts Directions Continued Section

  • WARNINGS

    30mL Sunscreen Label Drug Facts Warnings Section

  • INACTIVE INGREDIENT

    30mL Sunscreen Label Drug Facts Inactive Ingredient Section

  • INDICATIONS & USAGE

    30mL Sunscreen Label Drug Facts Uses Section

  • PRINCIPAL DISPLAY PANEL

    30mL Sunscreen 30mL Sunscreen Label PDPlabel Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    sunscreen, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83748-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    MYROTHAMNUS FLABELLIFOLIA LEAF (UNII: 6Y9E0R40J5)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    TOXICODENDRON SUCCEDANEUM FRUIT WAX (UNII: 684PA7HRMI)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83748-001-011 in 1 CARTON12/13/2023
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/13/2023
    Labeler - NATURAL AND ORGANIC FORMULATIONS (PTY) LTD (598865809)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL AND ORGANIC FORMULATIONS (PTY) LTD598865809manufacture(83748-001)
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!