ARTRA SKIN TONE FOR NORMAL SKIN- hydroquinone, homosalate, oxybenzone cream
J. Strickland & Co.

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.

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Artra Skin Tone Cream for Normal 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

12022-001-00

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12022-001-00	1 in 1 CARTON	12/01/1990	09/17/2020
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part358A	12/01/1990	09/17/2020

Labeler - J. Strickland & Co. (007023112)

Registrant - J. Strickland & Co. (007023112)

Name	Address	ID/FEI	Business Operations
Establishment
J. Strickland & Co.		007023112	manufacture(12022-001) , pack(12022-001) , label(12022-001)

Revised: 11/2020

Document Id: b34c9b12-012b-e6f0-e053-2a95a90a0ae2

Set id: f50c6e92-9089-4261-9597-200c0a0503ac

Version: 2

Effective Time: 20201104

J. Strickland & Co.