RODAN AND FIELDS ESSENTIALS LIP SHIELD BROAD SPECTRUM SPF 25- avobenzone, homosalate, octisalate, octocrylene stick

Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25 by

Drug Labeling and Warnings

Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25 by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.5%

Homosalate 8%

Octisalate 5%

Octocrylene 2.2%

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 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 a doctor if rash occurs.

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

Directions

• Apply liberally and evenly, covering lips completely. Apply liberally 15 minutes before sun exposure
• 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

Beeswax, Hydrogenated Avocado Oil, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Simmondsia Chinesis (Jojoba) Seed Oil, Acacia Decurrens / Jojoba / Sunflower Seed Wax / Polyglyceryl-3 Esters, Sunflower (Helianthus Annuus) Seed Oil Unsaponifiables, Dimethicone, Fragrance, Ethylhexyl Palmitate, Hydrogenated Polydecene, Dunaliella Salina Extract, Palmitoyl Tripeptide-1, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tribehenin, Sorbitan Isosterate.

Other information

Protect this product from excessive heat and sun.

Principal Display Panel - Essentials Lip Shield Outer Label

RODAN+FIELDS®

ESSENTIALS

Lip
Shield

BROAD
SPECTRUM
SPF 25

Contains 2 Tubes

4.25 g/.15 Oz. Ea.

Principal Display Panel - Essentials Lip Shield Primary Label

RODAN+FIELDS®

ESSENTIALS

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS ESSENTIALS LIP SHIELD BROAD SPECTRUM SPF 25 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-0425
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)
HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)
SHEA BUTTER (UNII: K49155WL9Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TEA TREE OIL (UNII: VIF565UC2G)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-0425-1	2 in 1 BOX	05/01/2017
1		4.25 g 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	05/01/2017

Labeler - Rodan & Fields (051659584)