Label: SUN THERAPE FACE SPF-35- octinoxate, octisalate, oxybenzone, avobenzone lotion

  • NDC Code(s): 67879-302-11, 67879-302-51
  • Packager: PHARMAGEL INTERNATIONAL 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 November 4, 2018

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

  • ACTIVE INGREDIENTS

    Octinoxate............................7.5%

    Octisalate.............................5.0%

    Oxybenzone..........................3.0%

    Avobenzone..........................3.0%

    Close
  • PURPOSE

    SUNSCREEN

    Close
  • USES

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

    Close
  • 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 doctor if rash occurs

    Close
  • KEEP OUT OF REACH OF CHILDREN

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

    Close
  • OTHER SAFETY INFORMATION

    Other Information
    • Protect the product in this container from excessive heat and direct sun

    Close
  • Directions For Sunscreen Use:

    • Apply liberally and evenly 15 minutes before sun exposure
    • 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 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
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months: Ask a doctor

    Close
  • INACTIVE INGREDIENTS:

    WATER (AQUA), ETHYLHEXYL PALMITATE, PROPYLENE GLYCOL, GLYCERYL STEARATE, PEG-100

    STEARATE, CETEARYL ALCOHOL, STEARIC ACID, DIMETHICONE, FRAGRANCE (PARFUM),

    PHENOXYETHANOL, MYRISTYL MYRISTATE, CAPRYLYL GLYCOL, HYDROXYETHYLCELLULOSE,

    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, ALLANTOIN, HEXYLENE

    GLYCOL, MYRISTYL LAURATE, PANTHENOL, TETRASODIUM EDTA, AMINOMETHYL PROPANOL, GLYCERIN,

    GLYCOLIC ACID, BUTYLENE GLYCOL, MORUS ALBA LEAF EXTRACT, BORAGO OFFICINALIS SEED OIL,

    BUTYLOCTYL SALICYLATE, COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE

    KOJIC ACID, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, MAGNESIUM ASCORBYL PHOSPHATE,

    NIACIN, PERSEA GRATISSIMA (AVOCADO) OIL, PHYLLANTHUS EMBLICA FRUIT EXRACT, ROSA CANINA

    (ROSE HIP) FRUIT EXTRACT, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE,

    UNDECYLENOYL PHENYLALANINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCYRRHIZA GLABRA

    (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CYPERUS ROTUNDUS

    ROOT EXTRACT, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA)

    EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED

    EXTRACT, GINKGO BILOBA LEAF EXTRACT, LIMONIUM GERBERI EXTRACT, SODIUM BENZOATE, LACTIC ACID,

    UNDECYLENIC ACID, POTASSIUM SORBATE, YELLOW 6 (CI 15985), LECITHIN, PLANKTON EXTRACT,

    CHLORPHENESIN, RED 40 (CI 16035), BENZOIC ACID, SORBIC ACID

    Close
  • Questions or Comments?

    Call toll free 800-882-4889

    Close
  • INGREDIENTS AND APPEARANCE
    SUN THERAPE FACE  SPF-35
    octinoxate, octisalate, oxybenzone, avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67879-302
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.0 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MYRISTYL LAURATE (UNII: 58U0NZN2BT)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
    BORAGE OIL (UNII: F8XAG1755S)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DEANOL BITARTRATE (UNII: D240J05W14)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    NIACIN (UNII: 2679MF687A)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CYPERUS ROTUNDUS TUBER (UNII: 4B51SRR959)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    GINKGO (UNII: 19FUJ2C58T)  
    LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    UNDECYLENIC ACID (UNII: K3D86KJ24N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67879-302-51 1 in 1 BOX 06/18/2015
    1 NDC:67879-302-11 100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 06/18/2015
    Labeler - PHARMAGEL INTERNATIONAL INC (603215182)
    Registrant - PHARMAGEL INTERNATIONAL INC (603215182)
    Close