Label: OI LIN NATURAL SUNSCREEN SPF 30- sunscreen, titanium dioxide emulsion

  • 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 February 6, 2012

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  • PURPOSE

    USES:  HELPS PREVENT SUNBURN

  • INDICATIONS & USAGE

    RECOMMENDATION:  APPLY OI-LIN® NATURAL EMULSION SPF 30 ON FACE AND OTHER AREAS OF THE BODY TO CREATE A NATURAL BARRIER BETWEEN YOUR SKIN AND HARMFUL EFFECTS OF THE SUN.  CHILDREN UNDER 6 MONTHS OF AGE; CONSULT A PHYSICIAN BEFORE USE.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:  TITANIUM DIOXIDE 6.4%

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS:  WATER (DEIONIZED), CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, JOJOBA ESTERS, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, VP/EICOSENE COPOLYMER, SORBITAN PALMITATE, CYCLOPENTASILOXANE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL WAX, OCTYLDODECYL, NEOPENTANOATE, POLYSORBATE 60, SORBITAN STEARATE, CETYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, DEMETHICONOL, RETINYL PALMITATE, TOCOPHERYL ACETATE, ORYZANOL, BISABOLOL, STEARYL GLYCYRRHETINATE, JASMINUM OFFICINALE, (JASMINE0 FLOWER EXTRACT, PERSEA GRATISSIMA (AVOCATO) OIL, TOCOPHEROL, ZINC OXIDE, SACCHARIDE HYDROLYSATE, MAGNESIUM ASPARTATE, BIOTIN, GLYCINE, ALANINE, UREA, ZEA MAYS (CORN) OIL, HYPERICUM PERFORATUM EXTRACT, XANTHAN GUM, ROYAL JELLY EXTRACT, CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE, BEESWAX, CHRYSANTHEMUM INDICUM FLOWER EXTRACT, IMPERATA CYLINDRICA (LALANG GRASS) ROOT EXTRACT, PINUS PINASTER BARK/BUD EXTRACT, VITIS VINIFERA (GRAPE) SEED OIL, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) EXTRACT, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, TRISODIUM EDTA, CITRIC ACID, FRAGRANCE.

  • WARNINGS

    WARNING:FOR EXTERNAL USE ONLY.  IF SWALLOWED, SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY, IF CONTACT WITH EYES OCCURS, RINSE THOROUGHLY WITH WATER.  DISCONTINUE USE AND CONSULT A PHYSICIAN IF PERSISTENT SIGNS OF IRRITATION OR RASH APPEAR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    MM1
    Jar 0.5 label

    MM2
    Jar 0.5 box

    MM3
    Jar 2.5 label

    MM4
    Jar 2.5 box

    USES: HELPS PREVENT SUNBURNS
  • INGREDIENTS AND APPEARANCE
    OI LIN NATURAL SUNSCREEN SPF 30 
    sunscreen, titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.66 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALANINE (UNII: OF5P57N2ZX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Biotin (UNII: 6SO6U10H04)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62191-004-0315 g in 1 JAR
    2NDC:62191-004-0471 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/1990
    Labeler - Sunrider Manufacturing L.P. (786951475)
    Registrant - Sunrider Manufacturing L.P. (786951475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sunrider Manufacturing L.P.786951475manufacture
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