RODAN AND FIELDS ESSENTIALS LIP SHIELD SPF 25- avobenzone, homosalate, octisalate, octocrylene lipstick

Rodan And Fields Essentials Lip Shield SPF 25 by

Drug Labeling and Warnings

Rodan And Fields Essentials Lip Shield SPF 25 by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields, Englewood Lab, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients            Purpose
Avobenzone 2.5%           Sunscreen
Homosalate 8%              Sunscreen
Octisalate 5%                 Sunscreen
Octocrylene 2.2%            Sunscreen

PURPOSE

Use Helps prevent sunburn.

WARNINGS

Warnings Stop use if skin rash occurs.

DOSAGE & ADMINISTRATION

Directions Apply liberally and evenly. Covering lips completely. For best result use daily and reapply frequently.

OTHER SAFETY INFORMATION

Other Information  You may report a serious adverse reaction ro Hodan + Fields. Attn: Product Development, 111 Maiden Lane, Suite 400, San Francisco, CA 94108.

INACTIVE INGREDIENT

Inactive Ingredients: Beeswax, Hydrogenated Avocado Oil, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Acacia Decurrens / Jojoba / Sunflower Seed Wax / Polyglyceryl-3 Esters, Sunflower (Helianthus Annuus) Seed Oil Unsaponifiables, Dimethicone, Fragrance, Ethylhexyl Palmitate, Hydrogenated Polydecane, Dunaliella Salina Extract, Palmiloyl Oligopeplkle, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Molaleuca Altosnilolia (Sea Tree) Leaf Oil, Tribehenin, Sorbitan Isostearate.

PRINCIPAL DISPLAY PANEL

8 84164 00530 5  RODAN+FIELDS ESSENTIALS  Dermatologist Developed Lip Shield SPF 25  Contains 2 Tubes - 4.25 g/ . 15 Oz. Each

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS ESSENTIALS LIP SHIELD SPF 25 
avobenzone, homosalate, octisalate, octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-425
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
AVOCADO OIL (UNII: 6VNO72PFC1)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TRIBEHENIN (UNII: 8OC9U7TQZ0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-425-01	2 in 1 PACKAGE
1		4.25 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/21/2011

Labeler - Rodan & Fields (051659584)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, LLC		172198223	manufacture