ARTRA SKIN TONE FOR NORMAL SKIN- hydroquinone, homosalate, oxybenzone cream

Artra Skin Tone for Normal Skin by

Drug Labeling and Warnings

Artra Skin Tone for Normal Skin by is a Otc medication manufactured, distributed, or labeled by J. Strickland & Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ARTRA SKIN TONE FOR NORMAL SKIN 
hydroquinone, homosalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12022-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	75 mg  in 1 g
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	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)
MINERAL OIL (UNII: T5L8T28FGP)
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: 12022-001-00	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(12022-001) , pack(12022-001) , label(12022-001)