FDA.reportPublic FDA data

Dermablue Daily Replenishing

Manufacturer
Dermablue, P.C. | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:49

Label at a glance#

ProductDermablue Daily Replenishing
Active ingredientZINC OXIDE
Label structure9 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 aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: 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 s...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

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 aging caused by the sun.

Warnings:

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure. • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: 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 am-2 pm •Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Other Information:

OTHER SAFETY INFORMATION

• Protect this product from excessive heat and direct sun

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385300208500GTIN-13: 0385300208500
EAN-13: 0385300208500
GTIN-12: 385300208500
UPC-A: 385300208500
GTIN storage (14 digits): 00385300208500		Lamond M.D. David Dermablue Daily Replenishing.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85300-208-50Dermablue Daily Replenishing50 g in 1 BOTTLE, PUMPCREAM502

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85300-20885300-208-50
58892-208

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CI 77492EX438O2MRTIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CERAMIDE 34370DF050BIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONE92RU3N3Y1OIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
ZINC OXIDESOI2LOH54ZACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
CI 774911K09F3G675IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CI 77499XM0M87F357IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermablue Daily ReplenishingZINC OXIDEDermablue, P.C.308da9c9-544e-d5d1-e063-6294a90aa49b2025-12-10WarningsExact identifier
ndc (package): 85300-208-50
ndc (product): 85300-208
ndc11 (package): 85300020850
spl id: 459c29eb-0128-ea05-e063-6394a90ac013
spl set id: 308da9c9-544e-d5d1-e063-6294a90aa49b
Proceuticals Private Label by TiZO tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd1cbcf8a6-0e83-f759-e063-6394a90ac14d2024-07-08WarningsExact identifier
ndc (product): 58892-208

Reported adverse events (FAERS/openFDA)#

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