ESSENTIALS Face and Body Sunscreen

Manufacturer
Rodan & Fields
Effective date
2020-04-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:02:56

Label at a glance#

ProductESSENTIALS Face and Body Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. When used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying 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 value of 15 or higher and other sun protection measures including:...

Label contents#

Full prescribing information#

Active Ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.8%, Homosalate 9.6%, Octisalate 4.8%, Octocrylene 9.6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. When 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 SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 80 minutes of swimming or sweating.
  • Reapply immediately after towel drying
  • 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 value 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.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Glycerin, Butylene Glycol, Pentylene Glycol, C12-15 Alkyl Benzoate, Silica, Dimethicone, Hydrogenated Lecithin, Fragrance/Parfum, Dimethicone/Vinyl Dimethicone Crosspolymer, Xanthan Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Carbomer, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Diethylhexyl Syringylidenemalonate, Aminomethyl Propanol, Citric Acid Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Citral, Limonene, Linalool, Titanium Dioxide (CI 77891).

Principal Display Panel – 150 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

ESSENTIALS

Face + Body
Sunscreen

Broad
Spectrum

SPF
50

Everyday
Active

Broad Spectrum SPF 50
Water Resistant (80 Minutes)

RODAN + FIELDS

150 mL/5.0 Fl. Oz. U.S.

Principal Display Panel – 150 mL Carton Label
Principal Display Panel – 150 mL Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-0002-12023-11-29C16284748780-10191ceaa-66e3-198a-e063-dbdaa90aec3eDrug Facts
14222-0002-12023-07-28C16284748780-10191ceaa-66e3-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-0002-1ESSENTIALS Face and Body Sunscreen150 mL in 1 TUBELOTION1504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-0002ESSENTIALS FACE AND BODY SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [RODAN & FIELDS]4Current NDC, Legacy NDC, 1 package rows20231130_dfc44a01-e8fd-43fc-b3cd-5cac17e4a5a3.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-000214222-0002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML · Source PDF

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESSENTIALS Face and Body SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fieldsdfc44a01-e8fd-43fc-b3cd-5cac17e4a5a32020-04-02WarningsExact identifier
ndc (package): 14222-0002-1
ndc (product): 14222-0002
ndc11 (package): 14222000201
spl id: 54c23103-18bf-4e79-aee0-f1d0864021df
spl set id: dfc44a01-e8fd-43fc-b3cd-5cac17e4a5a3

Reported adverse events (FAERS/openFDA)#

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