DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50- titanium dioxide, zinc oxide lotion 
Beautcella Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50+

Drug Facts

Active ingredients

Titanium Dioxide 8.85%

Zinc Oxide 1.91%

Purpose

Sunscreen

Uses

Warnings

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 doctor

if rash occurs.

Keep out of reach of children.

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

Directions

Other information

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

Questions?

212-708-3998

Inactive ingredients

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

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

www.DiSkincare.com

Product Packaging

frontback

DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81521-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE88.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
WATER (UNII: 059QF0KO0R)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LUTEIN (UNII: X72A60C9MT)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
BACOPA MONNIERI WHOLE (UNII: DUB5K84ELI)  
SHEA BUTTER (UNII: K49155WL9Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POVIDONE (UNII: FZ989GH94E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-12 GLYCERYL LAURATE (UNII: J07WW42G15)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
MILK THISTLE (UNII: U946SH95EE)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PROLINE (UNII: 9DLQ4CIU6V)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TEA TREE OIL (UNII: VIF565UC2G)  
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ACETYL L-TYROSINE (UNII: DA8G610ZO5)  
UREA (UNII: 8W8T17847W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81521-001-011 in 1 CARTON05/01/2021
125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2021
Labeler - Beautcella Inc. (928453625)

Revised: 2/2021
Document Id: bad942d8-04db-31d2-e053-2a95a90a9275
Set id: bad942d8-04da-31d2-e053-2a95a90a9275
Version: 1
Effective Time: 20210208
 
Beautcella Inc.