FDA.reportPublic FDA data

SOOTHE Daily Mineral Sunscreen

Manufacturer
Rodan & Fields
Effective date
2023-11-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:08

Label at a glance#

ProductSOOTHE Daily Mineral Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 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

Shake well before use. Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 40 minutes of swimming or sweating and 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.6%

Zinc Oxide 2.34%

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.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use.
  • Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 40 minutes of swimming or sweating and 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 AM - 2 PM.
    • 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

Acrylates/Dimethicone Copolymer, Aminopropyl Triethoxysilane, Ammonium Hydroxide, Aqua/Eau/Water, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Gluconate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dipropylene Glycol, Disteardimonium Hectorite, Ethylhexylglycerin, Gluconolactone, Glycerin, Isododecane, Isostearic Acid, Magnesium Sulfate, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Nylon-12, PEG-9 Polydimethylsiloxyethyl Dimethicone, Pentylene Glycol, Phenethyl Benzoate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Propanediol, Propylene Carbonate, Rosmarinic Acid, Rutin, Silica, Sodium Benzoate, Sodium Citrate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopherol, Triethylhexanoin.

Questions?

OTC - QUESTIONS SECTION

1-888-995-5656

Principal Display Panel - 30 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

SOOTHE

Daily Mineral Sunscreen

Broad Spectrum SPF 30

4

30 mL/ 1 Fl. Oz. U.S.

Principal Display Panel - 30 mL Carton Label
Principal Display Panel - 30 mL Carton Label

Principal Display Panel - 30 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

SOOTHE

4

Daily Mineral Sunscreen

Broad Spectrum SPF 30

Principal Display Panel - 30 mL Tube Label
Principal Display Panel - 30 mL Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-2440-12023-12-01C16284748780-10191ceaa-723d-198a-e063-dbdaa90aec3eDrug Facts
14222-2440-22023-12-01C16284748780-10191ceaa-723d-198a-e063-dbdaa90aec3eDrug Facts
14222-2440-32023-12-01C16284748780-10191ceaa-723d-198a-e063-dbdaa90aec3eDrug Facts
14222-2440-12023-07-28C16284748780-10191ceaa-723d-198a-e063-dbdaa90aec3eDrug Facts
14222-2440-22023-07-28C16284748780-10191ceaa-723d-198a-e063-dbdaa90aec3eDrug Facts
14222-2440-32023-07-28C16284748780-10191ceaa-723d-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-2440-1SOOTHE Daily Mineral Sunscreen1 in 1 CARTONLOTION14
14222-2440-1SOOTHE Daily Mineral Sunscreen30 mL in 1 BOTTLELOTION304
14222-2440-2SOOTHE Daily Mineral Sunscreen7 mL in 1 BOTTLELOTION74
14222-2440-2SOOTHE Daily Mineral Sunscreen1 in 1 CARTONLOTION14
14222-2440-3SOOTHE Daily Mineral Sunscreen2 mL in 1 PACKETLOTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-2440SOOTHE DAILY MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RODAN & FIELDS]4Current NDC, Legacy NDC, 5 package rows20231202_9acbf663-15e4-4572-a267-56afa58a347b.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-244014222-2440-1, 14222-2440-2, 14222-2440-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
3-(TRIETHOXYSILYL)PROPYLAMINEL8S6UBW552IACT
AMMONIA5138Q19F1XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CALCIUM GLUCONATESQE6VB453KIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CYNARA SCOLYMUS LEAFB71UA545DEIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
DIPROPYLENE GLYCOLE107L85C40IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
ISODODECANEA8289P68Y2IACT
ISOSTEARIC ACIDX33R8U0062IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
NYLON-12446U8J075BIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENETHYL BENZOATE0C143929GKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
PROPYLENE CARBONATE8D08K3S51EIACT
ROSMARINIC ACIDMQE6XG29YIIACT
RUTIN5G06TVY3R7IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
SOOTHE Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields9acbf663-15e4-4572-a267-56afa58a347b2023-11-30WarningsExact identifier
ndc (package): 14222-2440-2
ndc (package): 14222-2440-3
ndc (package): 14222-2440-1
ndc (product): 14222-2440
ndc11 (package): 14222244003
ndc11 (package): 14222244002
ndc11 (package): 14222244001
spl id: c84fcd08-13d4-4199-88d6-fb06f81a5b75
spl set id: 9acbf663-15e4-4572-a267-56afa58a347b

Reported adverse events (FAERS/openFDA)#

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