DERMABLUE DAILY REPLENISHING- zinc oxide cream

Dermablue Daily Replenishing by

Drug Labeling and Warnings

Dermablue Daily Replenishing by is a Otc medication manufactured, distributed, or labeled by Dermablue, P.C., Custom Analytics LLC, Fragrance Manufacturing Inc., Fallien Cosmeceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Zinc Oxide 16%

Purpose:

Sunscreen

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.

Warnings:

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:

• 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:

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:

Protect this product from excessive heat and direct sun

Warnings:

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMABLUE DAILY REPLENISHING 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85300-208(NDC:58892-208)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CI 77492 (UNII: EX438O2MRT)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CERAMIDE 3 (UNII: 4370DF050B)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77491 (UNII: 1K09F3G675)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CI 77499 (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85300-208-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/28/2023

Labeler - Dermablue, P.C. (089536875)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85300-208)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85300-208)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85300-208)