UVA/UVB SPF 15

Manufacturer: Rodan & Fields LLC. | Cosmetic Enterprises Ltd.
Effective date: 2012-01-24
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:30:43

Label at a glance#

ProductUVA/UVB SPF 15 Rodan and Fields

Active ingredientOCTINOXATE, ZINC OXIDE

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 3.4% Sunscreen

OTC - PURPOSE SECTION

Uses

Helps prevent sunburn
Higher SPF gives more sun protection
Temporarily protects chapped or cracked skin.

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 immediately.

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

Apply a generous dime-sized amount evenly over entire face every morning

Children under 6 months of age: ask a doctor.

Reapply as needed or after towel drying, swimming, or sweating.

INACTIVE INGREDIENT SECTION

Water, Octyldodecanol, Hydrogenated polydecene, butylene glycol, dimethicone, sodium dihydroxycetyl phosphate, glyceryl stearate, PEG-100 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, astrocaryum murumuru butter, Chamomilla recutita (matricaria) flower oil, Cucumis melo (melon) fruit extract, Persea Gratissima (avacado) oil, Cholesterol/Potassium sulfate, Acetyl glucosamine, squalene, Cholesterol, Linoleic acid, Bisabolol, Tocopheryl Acetate, Oleth-3 phosphate, propylene glycol dicaprylate ethylhexylglycerin, caprylyl glycol, triethoxycaprylylsilane, polysorbate 60, boron nitride, xanthan gum, tetrasodium EDTA, citric acid, potassium sorbate, phenoxyethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rodan and Fields

Soothe

UVA/UVB SPF 15 Sunscreen

50 mL/ 1.7 Fl. Oz.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
14222-2022-2	2019-11-13	C162847	48780-1	97449f38-bcab-f6ea-e053-dbdaa90aa703	UVA and UVB SPF 15 Sunscreen

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	3
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	3
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	3
ASTROCARYUM MURUMURU SEED BUTTER	INACTIVE INGREDIENT	12V64UPU6R	3
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	3
CANTALOUPE	INACTIVE INGREDIENT	8QF5D5H6UH	3
CHAMOMILE FLOWER OIL	INACTIVE INGREDIENT	60F80Z61A9	3
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
HYDROGENATED POLYDECENE (550 MW)	INACTIVE INGREDIENT	U333RI6EB7	3
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	3
OLETH-3 PHOSPHATE	INACTIVE INGREDIENT	8Q0Z18J1VL	3
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	3
SQUALENE	INACTIVE INGREDIENT	7QWM220FJH	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

UVA/UVB SPF 15 Rodan and Fields
Octinoxate, Zinc Oxide
OCTINOXATE
ZINC OXIDE
WATER
OCTYLDODECANOL
HYDROGENATED POLYDECENE (550 MW)
BUTYLENE GLYCOL
DIMETHICONE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
ASTROCARYUM MURUMURU SEED BUTTER
CHAMOMILE FLOWER OIL
CANTALOUPE
SQUALENE
CHOLESTEROL
OLETH-3 PHOSPHATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
14222-2022	14222-2022-1, 14222-2022-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
WATER	059QF0KO0R	IACT
OCTYLDODECANOL	461N1O614Y	IACT
HYDROGENATED POLYDECENE (550 MW)	U333RI6EB7	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
DIMETHICONE	92RU3N3Y1O	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
ASTROCARYUM MURUMURU SEED BUTTER	12V64UPU6R	IACT
CHAMOMILE FLOWER OIL	60F80Z61A9	IACT
CANTALOUPE	8QF5D5H6UH	IACT
SQUALENE	7QWM220FJH	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
OLETH-3 PHOSPHATE	8Q0Z18J1VL	IACT

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 · 45 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	FILM / TRANSDERMAL	32.44 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	CREAM / VAGINAL	0.3 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	LOTION / TOPICAL		714 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTABLE, LIPOSOMAL / INTRAVENOUS		437 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	0.32 %w/v		Exact identifier — unii candidate 10 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTABLE, LIPOSOMAL / INFILTRATION	0.47 %w/v		Exact identifier — unii candidate 10 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTION / INTRAVENOUS		93 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	GEL / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	FILM, EXTENDED RELEASE / TRANSDERMAL	253.4 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	LOTION / TOPICAL		20 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SYSTEM / TRANSDERMAL	4.05 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	CREAM / VAGINAL	13.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		7 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	52 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 3 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
44be628e-fe1d-4061-a3b2-5f1b72fb383b			016102bc-c0cd-485e-8cad-91c08a770fdb	2012-01-24		Exact identifier spl id: 44be628e-fe1d-4061-a3b2-5f1b72fb383b spl set id: 016102bc-c0cd-485e-8cad-91c08a770fdb

Reported adverse events (FAERS/openFDA)#

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