Label: SPF 30 BODY SUNSCREEN- avobenzone,octinoxate, octisalate, octocrylene, oxybenzone cream

  • 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 3, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Avobenzone - 2%

    Octinoxate - 7.5%

    Octisalate - 5%

    Octocrylene - 1.5%

    Oxybenzone - 6%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • High protection against sunburn.
    • Higher SPF gives more sunburn protection.
  • WARNINGS

    Warnings: For external use only.

  • WHEN USING

    When using this product keep out of eyes. Rinse with to remove.

  • ASK DOCTOR

    Stop use ans ask a doctor if rash occurs.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply generously 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply as needed or after towel drying, swimming or perspiring.
    • children under 6 months of age: ask a doctor.
  • STORAGE AND HANDLING

    Protect the product in in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua), C12-15 Alkyl Benzoate, Butylene Glycol, Octyldodecyl Neopentanoate, Cyclopentasiloxane, Cyclohexaciloxane, Caprylic/Capric Triglyceride, Glycerin, Sorbitan Oleate, Ubiquinone, Physalis Angulata Extract, Teprenone, Sodium Hyaluronate, Organic Camellia Sinensis Leaf Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Algae Extract, Artemisia Vulgaris Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Palmitoyl Pentapeptide-4, Leontopodium Alpinum Meristem Cell Culture, Plankton Extract, Micrococcus Lysate, Arabidopsis Thaliana Extract, Organic Aloe Barbadensis Leaf Juice, Polygonum Aviculare Extract, Xanthan Gum, Lecithin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Fragrance, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    Made in USA

    Distributed By OJAS, LLC

    OjasSkin.com

    image description

  • INGREDIENTS AND APPEARANCE
    SPF 30 BODY SUNSCREEN 
    avobenzone,octinoxate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4079
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    TEPRENONE (UNII: S8S8451A4O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ACTINIDIA CHINENSIS ROOT (UNII: 1L6O0O338I)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4079-21 in 1 CARTON
    1NDC:62742-4079-1120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/03/2015
    Labeler - Alure Labs, Inc. (926831603)
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