Label: ARTRA SKIN TONE FOR OILY SKIN- hydroquinone, homosalate, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 18, 2018

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

  • Active Ingredients

    Hydroquinone, 7.5%

    Homosalate, 2%

    Oxybenzone, 2.5%

    Purpose

    Sunscreen

    Skin Lightener

    Sunscreen

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  • Uses:

    Gradually fades skin discolorations such as

    • age spots
    • freckles
    • Liver spots
    • dark areas that can occur while using oral contraceptives
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  • Warnings:

    For external use only

    Do not use

    • to prevent sunburn
    • if product is tan or brown
    • on inflamed or broken skin

    When using this product

    • mild irritation may occur
    • avoid contact with eyes. if contact occurs, rinse with water.
    • avoid unnecessary sun exposure and use a sunscreen or protective clothing

    Stop use and consult a doctor if 

    • a gradual blue-black darking of the skin occurs
    • irritation becomes severe
    • no improvement is seen after 3 months

    If pregnant or breast feeding

    consult a health professional before use.

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a poison control center.

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  • Directions

    • If skin is sensitive, test on a small area inside elbow overnight before use.
    • Adults and Children 12 years and older: apply as a thin layer to affected area twice daily or as directed by a doctor.
    • Children under 12 years of age: ask a doctor before use.
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  • Inactive Ingredients

    water, glyceryl stearate, myristyl myristate, PEG-100 stearate, magnesium aluminum silicate, cetyl alcohol, dimenthicone, xanthan gum, stearic acid, palmitic acid, sodium sulfite, sodium lauryl sulfate, fragrance, citric acid, carathamus tinctorius (safflower) seed oil, ascorbic acid, methylparaben, tocopheryl acetate, aloe barbadensis leaf extract.

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  • Package Labeling
  • INGREDIENTS AND APPEARANCE
    ARTRA SKIN TONE FOR OILY SKIN 
    hydroquinone, homosalate, oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:12022-000
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 75 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 20 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 25 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12022-000-00 1 in 1 CARTON 12/01/1990
    1 57 g 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 not final part358A 12/01/1990
    Labeler - J. Strickland & Co. (007023112)
    Registrant - J. Strickland & Co. (007023112)
    Establishment
    Name Address ID/FEI Business Operations
    J. Strickland & Co. 007023112 manufacture(12022-000) , pack(12022-000) , label(12022-000)
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