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Rodan And Fields Essentials Lip Shield SPF 25

Dosage form: lipstick
Ingredients: AVOBENZONE 2.5g in 100g, HOMOSALATE 8g in 100g, OCTISALATE 5g in 100g, OCTOCRYLENE 2.2g in 100g
Labeler: Rodan & Fields
NDC Code: 14222-425

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Rodan + Fields Essentials Lip Shield SPF 25

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

Use Helps prevent sunburn.

Warnings Stop use if skin rash occurs.

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

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 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.

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

RODAN AND FIELDS ESSENTIALS LIP SHIELD SPF 25 
avobenzone, homosalate, octisalate, octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-425
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.5 g  in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE8 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE2.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
AVOCADO OIL 
SHEA BUTTER 
JOJOBA OIL 
HELIANTHUS ANNUUS SEED WAX 
SUNFLOWER OIL 
DIMETHICONE 
ETHYLHEXYL PALMITATE 
DUNALIELLA SALINA 
TETRAHEXYLDECYL ASCORBATE 
VITAMIN A PALMITATE 
TRIBEHENIN 
Packaging
#Item CodePackage Description
1NDC:14222-425-012 TUBE (TUBE) in 1 PACKAGE
14.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/21/2011
Labeler - Rodan & Fields (051659584)
Establishment
NameAddressID/FEIOperations
Englewood Lab, LLC172198223manufacture

Revised: 06/2011
 
Rodan & Fields

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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