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Artra Skin Tone for Dry Skin

Medically reviewed on January 18, 2018

Dosage form: cream
Ingredients: HOMOSALATE 75mg in 1g, HYDROQUINONE 20mg in 1g, OXYBENZONE 25mg in 1g
Labeler: J. Strickland & Co.
NDC Code: 12022-002

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.

Artra Skin Tone Cream for Dry Skin

Active Ingredients:

Homosalate, 7.5%

Hydroquinone, 2%

Oxybenzone, 2.5%

Purpose

Sunscreen

Skin Lightener

Sunscreen

Uses:

Gradually fades skin discolorations such as

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

Warnings:

For External Use Only.

Do not use on
  • 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 usa a sunscreen or protective clothing

Stop use and ask a doctor if
  • a gradual blue-black drakening 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, getmedical help or contact a poison control center.

Directions:
  • If skin is sensitive, test on a small area inside the 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 use.

Other Ingredients:

water, glyceryl stearate, myristyl myristate, PEG-100 stearate, mineral oil, 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.

Package Labeling

ARTRA SKIN TONE FOR DRY SKIN 
hydroquinone, homosalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE75 mg  in 1 g
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE20 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MYRISTYL MYRISTATE 
PEG-100 STEARATE 
MINERAL OIL 
MAGNESIUM ALUMINUM SILICATE 
CETYL ALCOHOL 
DIMETHICONE 
XANTHAN GUM 
STEARIC ACID 
PALMITIC ACID 
SODIUM SULFITE 
SODIUM LAURYL SULFATE 
CITRIC ACID MONOHYDRATE 
ASCORBIC ACID 
METHYLPARABEN 
.ALPHA.-TOCOPHEROL ACETATE 
ALOE VERA LEAF 
WATER 
GLYCERYL MONOSTEARATE 
Packaging
#Item CodePackage Description
1NDC:12022-002-001 TUBE in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A12/01/1990
Labeler - J. Strickland & Co. (007023112)
Registrant - J. Strickland & Co. (007023112)
Establishment
NameAddressID/FEIOperations
J. Strickland & Co.007023112manufacture(12022-002), pack(12022-002), label(12022-002)

 
J. Strickland & Co.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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