Label: SUN THERAPE PRO SPORT SPF-35- homosalate, octinoxate, oxybenzone, octocrylene, octisalate, avobenzone spray

  • NDC Code(s): 67879-306-11, 67879-306-51
  • 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

    Homosalate..................15%
    Octinoxate.....................7.5%
    Oxybenzone..................6.0%

    Octocrylene................5.5%
    Octisalate ...................5.0%
    Avobenzone................3.0%

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  • PURPOSE

    SUNSCREEN

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  • 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

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  • 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

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  • 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.

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  • OTHER SAFETY INFORMATION

    • Flammable: Keep away from flame or high heat. Avoid spraying in eyes. Contents under pressure. DO not puncture or incinerate. DO not store at temperature above 120ºF.

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

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  • 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

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  • INACTIVE INGREDIENTS:

    ALCOHOL DENAT, POLYESTER-8, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, ETHOXYDIGLYCOL, COCOS NUCIFERA (COCONUT) OIL, BUTYLENE GLYCOL, TRISILOXANE, FRAGRANCE (PARFUM), TOCOPHERYL ACETATE, DIMETHICONE, POLYESTER-10, PROPYLENE GLYCOL DIBENZOATE, GARDENIA TAHITENSIS (TIARE) FLOWER, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, PANTHENOL, PERSEA GRATISSIMA (AVOCADO) OIL, TETRAHEXYLDECYL ASCORBATE, WATER (AQUA), SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ALOE BARBADENSIS LEAF JUICE, PHENOXYETHANOL, DIMETHYLAMINOETHANOL TARTRATE, ROSA CANINA (ROSE HIP) FRUIT EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CHLORPHENESIN, BENZOIC ACID, SORBIC ACID, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, LIMONIUM GERBERI EXTRACT, LECITHIN PLANKTON EXTRACT, CITRIC ACID, SODIUM BENZOATE

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  • Questions or Comments?

    Call toll free 800-882-4889

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  • INGREDIENTS AND APPEARANCE
    SUN THERAPE PRO SPORT  SPF-35
    homosalate, octinoxate, oxybenzone, octocrylene, octisalate, avobenzone spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67879-306
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    OCTYL ACRYLATE (UNII: EJN94319DN)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYESTER-10 (UNII: 212N9O2MMZ)  
    PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    BORAGE OIL (UNII: F8XAG1755S)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    WATER (UNII: 059QF0KO0R)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DEANOL BITARTRATE (UNII: D240J05W14)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SORBIC ACID (UNII: X045WJ989B)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
    LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67879-306-51 1 in 1 BOX 06/10/2016
    1 NDC:67879-306-11 125 mL in 1 BOTTLE, SPRAY; 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 06/10/2016
    Labeler - PHARMAGEL INTERNATIONAL INC (603215182)
    Registrant - PHARMAGEL INTERNATIONAL INC (603215182)
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