FDA.reportPublic FDA data

EltaMD UV Physical Rosy Tint SPF40

Manufacturer
CP Skin Health Group, Inc | Swiss-American CDMO, LLC
Effective date
2024-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:24:15

Label at a glance#

ProductEltaMD UV Physical Rosy Tint SPF40
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measure (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: after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in th...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide   7.0%

Zinc Oxide    9.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Indications & Uses:

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply: after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, isopropyl plamitate, ethylhexyl stearate, octyldodecyl neopentanoate, alumina, polyacrylate-13, phenoxyethanol, hydrogen dimethicone, polyisobutene, triethoxycaprylylsilane, oleth-3 phosphate, citric acid, tocopheryl acetate, bisabolol, tocopherol, ethylhexylglycerin, carnosine, polysorbate 20, sodium hydroxide, phosphoric acid, canola oil, zingiber officinale (ginger) root extract, iron oxides

Questions?

OTC - QUESTIONS SECTION

Call 1-800-633-8872

visit www.eltamd.com

labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV Phyiscal Rosy TintUV Phyiscal Rosy Tint

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72043-2257-1EltaMD UV Physical Rosy Tint SPF4048 g in 1 TUBELOTION481
72043-2257-2EltaMD UV Physical Rosy Tint SPF402 g in 1 PACKETLOTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2257ELTAMD UV PHYSICAL ROSY TINT SPF40 (TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN) LOTION [CP SKIN HEALTH GROUP, INC]1Current NDC, 2 package rows20241012_6bc4d2d4-ef62-4ec0-b514-17257603bac2.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-225772043-2257-1, 72043-2257-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
POLYACRYLATE-13FS2D4T67EAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROGENATED POLYISOBUTENE (450 MW)7YR4ZFS62EIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TOCOPHEROLR0ZB2556P8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CARNOSINE8HO6PVN24WIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHOSPHORIC ACIDE4GA8884NNIACT
CANOLA OIL331KBJ17RKIACT
ZINGIBER OFFICINALE WHOLEIN6Q3S3414IACT
ALUMINUM OXIDELMI26O6933IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LEVOMENOL24WE03BX2TIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
POLYISOBUTYLENE (45000 MW)YR8AQ94O31IACT

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
EltaMD UV Physical Rosy Tint SPF40TITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6bc4d2d4-ef62-4ec0-b514-17257603bac22024-09-05WarningsExact identifier
ndc (package): 72043-2257-2
ndc (package): 72043-2257-1
ndc (product): 72043-2257
ndc11 (package): 72043225702
ndc11 (package): 72043225701
spl id: ee263928-c82b-4738-9b47-d72ef8b82930
spl set id: 6bc4d2d4-ef62-4ec0-b514-17257603bac2

Reported adverse events (FAERS/openFDA)#

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