FDA.reportPublic FDA data

Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50

Manufacturer
Beautcella Inc.
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:04

Label at a glance#

ProductDerm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 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 the sun.

Dosage and administration

Use in the a.m. after serum and before foundation or makeup apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.85%

Zinc Oxide 1.91%

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 the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on 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 a doctor

OTC - STOP USE SECTION

if 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

  • Use in the a.m. after serum and before foundation or makeup
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor
  • 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 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses

Other information

OTHER SAFETY INFORMATION

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

Questions?

OTC - QUESTIONS SECTION

212-708-3998

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isononyl Isononanoate, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl Ethylhexanoate, Propanediol, Sodium Chloride, Diethylhexyl Carmonate, Stearic Acid, Alumina, Disteardimonium Hectorite, Polyhydroxystearic Acid, Iron Oxides (CI 77492), Phenoxyethanol, Bacopa Monnieri Extract, Lavandula Angustifolia (Lavender) Oil, Polyglyceryl-6 Polyricinoleate, Glycerin, Butyrospermum Parkii (Shea) Butter, Acetyl Tyrosine, Tocopheryl Acetate, Urea, Allantoin, o-Cymen-5-ol, Iron Oxides (CI 77491), Proline, Ethylhexylglycerin, Iron Oxides (CI 77499), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Hydroxyethylcellulose, Xanthophylls, PEG-12 Glyceryl Laurate, Rosmarinus Officininalis (Rosemary) Leaf Oil, PEG-35 Castor Oil, PVP, Lecithin, Alteromonas Ferment Extract, Magnesium Ascorbyl Phosphate, Silybum Marianum Extract, Potassium Sorbate, Caprylyl Glycol, Disodium EDTA, Tocopherol, Xanthan Gum, Ergothioneine, Chondrus Crispus Extract

Company Information

SPL UNCLASSIFIED SECTION

Distributed by: Beautcella Inc. New York, NY 10021 USA

www.DiSkincare.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

frontfrontbackback

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81521-001-012024-12-06C16284748780-11030e365-5c62-111a-e063-dadaa90a10e2Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50+
81521-001-012024-01-30C16284748780-11030e365-5c62-111a-e063-dadaa90a10e2Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50+

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81521-001-01Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF501 in 1 CARTONLOTION12
81521-001-01Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF5025 mL in 1 BOTTLE, PLASTICLOTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81521-001DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BEAUTCELLA INC.]2Current NDC, Legacy NDC, 2 package rows20241208_bad942d8-04da-31d2-e053-2a95a90a9275.zip

Products#

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

DailyMed product names page 1 of 2 · 50 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81521-00181521-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
ADENOSINE TRIPHOSPHATE8L70Q75FXEIACT
PROLINE9DLQ4CIU6VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TEA TREE OILVIF565UC2GIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
POLYOXYL 35 CASTOR OIL6D4M1DAL6OIACT
XANTHAN GUMTTV12P4NEEIACT
UREA8W8T17847WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ACETYL L-TYROSINEDA8G610ZO5IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIETHYLHEXYL CARBONATEYCD50O0Z6LIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CETYL ETHYLHEXANOATE134647WMX4IACT
WATER059QF0KO0RIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
O-CYMEN-5-OLH41B6Q1I9LIACT
FERRIC OXIDE RED1K09F3G675IACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
LUTEINX72A60C9MTIACT
ROSEMARY OIL8LGU7VM393IACT
BACOPA MONNIERI WHOLEDUB5K84ELIIACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALLANTOIN344S277G0ZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PROPANEDIOL5965N8W85TIACT
ALUMINUM OXIDELMI26O6933IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
EDETATE DISODIUM7FLD91C86KIACT
POVIDONEFZ989GH94EIACT
ERGOTHIONEINEBDZ3DQM98WIACT

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
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50TITANIUM DIOXIDE, ZINC OXIDEBeautcella Inc.bad942d8-04da-31d2-e053-2a95a90a92752024-12-06WarningsExact identifier
ndc (package): 81521-001-01
ndc (product): 81521-001
ndc11 (package): 81521000101
spl id: 289b1fa4-87a1-05f4-e063-6294a90a70ee
spl set id: bad942d8-04da-31d2-e053-2a95a90a9275

Reported adverse events (FAERS/openFDA)#

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