Label: SUN ESSENTIAL- octinoxate titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 1, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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 product is swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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. Protect this product from excessive heat and direct sun

  • INACTIVE INGREDIENT

    ALANINE, ALOE VERA LEAF, ARGININE, ASCORBIC ACID, ASCORBYL PALMITATE, .ALPHA.-BISABOLOL, (+/-)-,CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, CETEARYL ISONONANOATE, CETYL ALCOHOL, CITRIC ACID MONOHYDRATE, COCONUT, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL MONOSTEARATE, GLYCINE, SUNFLOWER OIL, MICA, NIACIN, OLEA EUROPAEA LEAF, PANTHENOL, PHENOXYETHANOL, LECITHIN, SOYBEAN, POTASSIUM SORBATE, SODIUM PYROPHOSPHATE, PENTYLENE GLYCOL, PROPANEDIOL, ALMOND OIL, ROSA MOSCHATA OIL, ROSEMARY, HYALURONATE SODIUM, SODIUM CITRATE, SORBITAN, TOCOPHEROL, UREA, GRAPE SEED OIL, XANTHAN GUM, WATER

  • PURPOSE

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    For external use only.
    Avoid contact with eyes.
    Keep out of reach of children.
    Do not apply to open wounds.
    STOP USE AND ask a doctor if condition worsens or
    symptoms persist for more than seven days, discontinue
    use of the product.

  • PRINCIPAL DISPLAY PANEL

    image of label

  • ACTIVE INGREDIENT

    Titanium Dioxide, Octinoxate

  • INGREDIENTS AND APPEARANCE
    SUN ESSENTIAL 
    octinoxate titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE17.75 g  in 355 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE14.2 g  in 355 g
    Inactive Ingredients
    Ingredient NameStrength
    ALANINE (UNII: OF5P57N2ZX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARGININE (UNII: 94ZLA3W45F)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT (UNII: 3RT3536DHY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCINE (UNII: TE7660XO1C)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MICA (UNII: V8A1AW0880)  
    NIACIN (UNII: 2679MF687A)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    ROSEMARY (UNII: IJ67X351P9)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    UREA (UNII: 8W8T17847W)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-009-06355 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2012
    Labeler - CA-BOTANA INTERNATIONAL (106276728)
    Registrant - RODOLFO UGELSTAD (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-BOTANA INTERNATIONAL106276728manufacture
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

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!