FDA.reportPublic FDA data

Personalized Day Moisturizer with SPF 50

Manufacturer
Proven Skincare
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:55

Label at a glance#

ProductPersonalized Day Moisturizer with SPF 50
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

• Helps Prevent Sunburn. ▪If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by sun.

Dosage and administration

• Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months of age: Ask a doctor 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: ▪ Lim...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps Prevent Sunburn. ▪If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by sun.

Warnings

WARNINGS SECTION

  • For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months of age: Ask a doctor

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 sleeved shirts, pants, hats, and sunglasses. Sun Protection Measures

Inactive Ingredients

INACTIVE INGREDIENT SECTION

• Water, Caprylic/Capric Triglyceride, Isoamyl Laurate, Squalane, Butyloctyl Salicylate, Jojoba Esters, Glycerin, Methylpropanediol, Cetyl Alcohol, Glyceryl Stearate, Silica, Polyglyceryl-2 Dipolyhydroxystearate, PEG-75 Stearate, Caprylyl Glycol, Allantoin, Fragrance, Pyrus Malus (Apple) Fruit Extract, Lysolecithin, Sclerotium Gum, Lecithin, Phenylpropanol, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Tetrasodium Glutamate Diacetate, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Tocopherol, Sodium Hydroxide

Other Information

SPL UNCLASSIFIED SECTION

• Protect the product in this container from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

go to www.provenskincare.com Made in USA from local and imported materialsManufactured for PROVEN, Miami, FL, 33131

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
73572-007-01Personalized Day Moisturizer with SPF 5030 mL in 1 BOTTLECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73572-007PERSONALIZED DAY MOISTURIZER WITH SPF 50 (ZINC OXIDE) CREAM [PROVEN SKINCARE]2Current NDC, Legacy NDC, 1 package rows20231111_bb921e91-9faf-4210-9091-ab511af9012a.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73572-00773572-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ISOAMYL LAURATEM1SLX00M3MIACT
SQUALANEGW89575KF9IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
PEG-75 STEARATEOT38R0N74HIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALLANTOIN344S277G0ZIACT
APPLEB423VGH5S9IACT
BETASIZOFIRAN2X51AD1X3TIACT
PHENYLPROPANOL0F897O3O4MIACT
PULLULAN8ZQ0AYU1TTIACT
XANTHAN GUMTTV12P4NEEIACT
CETETH-20I835H2IHHXIACT
STEARETH-20L0Q8IK9E08IACT
ALOE VERA LEAFZY81Z83H0XIACT
LEVOMENOL24WE03BX2TIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM HYDROXIDE55X04QC32IIACT
ZINC OXIDESOI2LOH54ZACTIM

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
Personalized Day Moisturizer with SPF 50ZINC OXIDEProven Skincarebb921e91-9faf-4210-9091-ab511af9012a2023-11-10WarningsExact identifier
ndc (package): 73572-007-01
ndc (product): 73572-007
ndc11 (package): 73572000701
spl id: 09cc9eb2-c5b1-d6fa-e063-6394a90a4ea2
spl set id: bb921e91-9faf-4210-9091-ab511af9012a

Reported adverse events (FAERS/openFDA)#

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