SKIN MD NATURAL- octinoxate, octisalate, homosalate lotion

skin MD Natural by

Drug Labeling and Warnings

skin MD Natural by is a Otc medication manufactured, distributed, or labeled by 21st Century Formulations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7%

Octisalate 5%

Homosalate 3%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• Decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

Do not use

on damaged or broken skin

Stop use and ask a Doctor

if rash occurs.

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.

  Spending time in the sun increases your risk of skin cancer and early skin aging.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water (aqua), Aloe Barbadensis Leaf Extract (Aloe Vera), Cyclopentasiloxane, Dimethicone, Methyl Gluceth-20, Extracts of Arnica Montana Flower (Arnica), Symphytum Officinale Leaf (Camfrey), Chamomilla Recutita (Matricaria Chamomile), Achillea Millefolium (Yarrow), Chondrus Crispus (Carrageenan), Tocopheryl Acetate (Vitamin E), Sorbitan Oleate, 1,2 Hexanediol, Caprylyl Gylcol, Butylene Glycol, Aminomethyl Propanol, Phenoxyethanol (preservative), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-Hydroxyethoxypropyl Dimethicone.

Questions?

Call toll free 1-800-540-4790

®2013 Made in USA

21st Century Formulations

Beverly Hills, CA 90210

www.skinmdnatural.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN MD NATURAL 
octinoxate, octisalate, homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44099-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
COMFREY LEAF (UNII: DG4F8T839X)
CHAMOMILE (UNII: FGL3685T2X)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44099-001-01	117 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2008
2	NDC: 44099-001-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2008
3	NDC: 44099-001-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2008
4	NDC: 44099-001-04	100 mL in 1 TUBE; Type 0: Not a Combination Product	07/16/2018
5	NDC: 44099-001-05	200 mL in 1 TUBE; Type 0: Not a Combination Product	07/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/19/2008

Labeler - 21st Century Formulations (039644618)