RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30

Manufacturer
Rodan & Fields | Englewood Lab, Inc.
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:04:01

Label at a glance#

ProductRODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

To protect from sunburn and sun-induced skin irritations.

Dosage and administration

Shake well before use. Apply a generous dime-sized amount evenly over the entire face every morning as the final step in the Regimen. Reapply every 2 - 3 hours as needed. Avoid the eye area. Children under 6 months of age: ask a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 2% Zinc Oxide 12%

PURPOSE

OTC - PURPOSE SECTION

Sunscreens

USES:

INDICATIONS & USAGE SECTION

To protect from sunburn and sun-induced skin irritations.

WARNINGS:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop use and ask a doctor

OTC - STOP USE SECTION

If rash occurs.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Apply a generous dime-sized amount evenly over the entire face every morning as the final step in the Regimen. Reapply every 2 - 3 hours as needed. Avoid the eye area. Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Starch Octenylsuccinate, Butylene Glycol, Camellia Sinesis Extract, Caprylyl Glycol, Caprylyl Methicone, Cyclopentasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hydrolyzed Wheat Protein/PVP Crosspolymer, Methicone, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Silica, Sodium Chloride, Sodium Hyaluronate, Sodium PCA, Tocopheryl Acetate, Water

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

RODAN + FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 50ml (14222-0000-1)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


BottleLabelBottleLabel

OuterLabelOuterLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-0000-1RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 3050 mL in 1 TUBECREAM5011
14222-0000-1RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 301 in 1 CARTONCREAM111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-0000RODAN FIELDS SOOTHE 4 MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE) CREAM [RODAN & FIELDS]11Current NDC, Legacy NDC, 2 package rows20231213_1a936053-2be0-4c52-a073-ba846b87f811.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP3
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z3
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP3
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O62943
CAMELLIA SINENSIS FLOWERINACTIVE INGREDIENT9I2BJY2J173
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3
CAPRYLYL TRISILOXANEINACTIVE INGREDIENTQ95M2P1KJL3
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C53
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX3
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH3
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)INACTIVE INGREDIENTJ2S07SB0YL3
LICORICEINACTIVE INGREDIENT61ZBX548833
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X3
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A23
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-000014222-0000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

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 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii+route
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route
2 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii+route
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
ALUMINUM STARCH OCTENYLSUCCINATEALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294CREAM / TOPICAL321 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
ALUMINUM STARCH OCTENYLSUCCINATEALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294CREAM / TOPICAL321 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route
4 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30TITANIUM DIOXIDERodan & Fields1a936053-2be0-4c52-a073-ba846b87f8112023-12-12WarningsExact identifier
ndc (package): 14222-0000-1
ndc (product): 14222-0000
ndc11 (package): 14222000001
spl id: 0c5af7db-48bf-d979-e063-6294a90af24e
spl set id: 1a936053-2be0-4c52-a073-ba846b87f811

Reported adverse events (FAERS/openFDA)#

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