UNBLEMISH INVISIBLE MATTE DEFENSE- homosalate, octocrylene, octisalate, avobenzone gel

UNBLEMISH Invisible Matte Defense by

Drug Labeling and Warnings

UNBLEMISH Invisible Matte Defense by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%,

Octocrylene 10%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• When used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask doctor

• if rash occurs.

Keep out of reach of children. If swallowed, get medical help right away.

Directions

• Apply liberally over entire face at least 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.

• Sun Protection Measures.

  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients:

lsododecane, Dimethicone Crosspolymer, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Silica, C12-15 Alkyl Benzoate, Polysilicone-22, Glycerin, Linoleic Acid, Linolenic Acid, Oleic Acid, Palmitic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Divinyldimethicone/Dimethicone/Phenylsilsesquioxane Crosspolymer, Polymethylsilsesquioxane, Silica Silylate, Stearic Acid, Tocopherol, Ethylhexylglycerin, Benzyl Alcohol

Questions?

1-888-995-5656

Principal Display Panel – 30 mL Carton Label

RODAN+FIELDS

UNBLEMISH

4
Invisible
Matte Defense

Broad Spectrum SPF 30

RODAN+FIELDS

Gel

30 mL/1 Fl. Oz. U.S.

Principal Display Panel – 30 mL Tube Label

RODAN+FIELDS

UNBLEMISH

4
Invisible
Matte Defense

Broad Spectrum SPF 30

INGREDIENTS AND APPEARANCE

UNBLEMISH INVISIBLE MATTE DEFENSE 
homosalate, octocrylene, octisalate, avobenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.1 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.1 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LINOLENIC ACID (UNII: 0RBV727H71)
OLEIC ACID (UNII: 2UMI9U37CP)
PALMITIC ACID (UNII: 2V16EO95H1)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2131-1	1 in 1 CARTON	03/10/2020
1		30 mL 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	part352	03/10/2020

Labeler - Rodan & Fields (051659584)