FDA.reportPublic FDA data

Rodan And Fields Essentials Lip Shield SPF 25

Manufacturer
Rodan & Fields | Englewood Lab, LLC
Effective date
2011-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:28:22

Label at a glance#

ProductRodan And Fields Essentials Lip Shield SPF 25
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Use Helps prevent sunburn.

WARNINGS SECTION

Warnings Stop use if skin rash occurs.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.

PACKAGE LABEL.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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rodan Lip Shield SPF 25Rodan Lip Shield SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-425-01Rodan And Fields Essentials Lip Shield SPF 254.25 g in 1 TUBELIPSTICK4.251
14222-425-01Rodan And Fields Essentials Lip Shield SPF 252 in 1 PACKAGELIPSTICK21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-425RODAN AND FIELDS ESSENTIALS LIP SHIELD SPF 25 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LIPSTICK [RODAN & FIELDS]12 package rows20110622_3c024354-adc4-4514-9388-5f25df67c2ab.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC11
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DUNALIELLA SALINAINACTIVE INGREDIENTF4O1DKI9A61
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933091
HELIANTHUS ANNUUS SEED WAXINACTIVE INGREDIENT42DG15CHXV1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZ1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ01
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-42514222-425-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
YELLOW WAX2ZA36H0S2VIACT
AVOCADO OIL6VNO72PFC1IACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
SUNFLOWER OIL3W1JG795YIIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL PALMITATE2865993309IACT
DUNALIELLA SALINAF4O1DKI9A6IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TRIBEHENIN8OC9U7TQZ0IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fieldsc7526b69-d059-499a-9134-3a1f5d0471b32023-12-12WarningsExact identifier
ndc11 (package): 14222042501
04b587d3-dc74-4b82-b07a-fae977c2af903c024354-adc4-4514-9388-5f25df67c2ab2011-06-22WarningsExact identifier
spl id: 04b587d3-dc74-4b82-b07a-fae977c2af90
spl set id: 3c024354-adc4-4514-9388-5f25df67c2ab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.