RODAN AND FIELDS REDEFINE AM SPF 30- octisalate, avobenzone, octocrylene, homosalate cream

Rodan and Fields Redefine AM by

Drug Labeling and Warnings

Rodan and Fields Redefine AM by is a Otc medication manufactured, distributed, or labeled by Rodan and Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone  3%

Homosalate  2.5%

Octisalate  5%

Octocrylene  2.7%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If 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

Warnings    For external use onyl

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 a doctor if rash occurs

Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply a dime-sized amount evenly over entire face every morning and 15 minutes before sun exposure, avoiding the eye area.
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours.
• 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 a broad spectrum SPF 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.

Inactive ingredients

Water, Isododecane, Ethylhexyl Pamitate, Polymethylsilsesquioxane, Glycerin, Dimethicone, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Caprylyl Glycol, Sucrose Stearate, Olea Europaea (Olive) Fruit Extract, Hydrogenated Polydecene, Polyurethane-40, Hydrolyzed Silk, Fragrance, Silica, Camellia Oleifera Leaf Extract, Polyacrylate-13, Polyisobutene, Polysorbate-20, Iron Oxides, Tetrapeptide-21,  Resveratrol, Phenoxyethanol, Chlorphenesin, Dunaliella Salina Extract, Talc, PEG-12 Dimethicone, Humic Acids, Sodium Hyaluronate

Other Information

Protect this product from excessive heat and direct sun

QUESTIONS

QUESTIONS OR COMMENTS   1-888-995-5656

HOW SUPPLIED

Manufactured for Rodan and Fields, LLC

11 Maiden Lane, Suite 400

San Francisco, CA 94108

Made in USA  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS REDEFINE AM  SPF 30
octisalate, avobenzone, octocrylene, homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUCROSE STEARATE (UNII: 274KW0O50M)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TETRAPEPTIDE-21 (UNII: 179JUC43HU)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
BLACK OLIVE (UNII: 2M6QWV94OC)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
RESVERATROL (UNII: Q369O8926L)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2250-2	1 in 1 CARTON	05/01/2013
1	NDC: 14222-2250-1	30 mL in 1 JAR; 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	05/01/2013

Labeler - Rodan and Fields (051659584)