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

Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50 by

Drug Labeling and Warnings

Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50 by is a Otc medication manufactured, distributed, or labeled by Beautcella Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium Dioxide 8.85%

Zinc Oxide 1.91%

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 skin aging caused by the sun.

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

• 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

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

INGREDIENTS AND APPEARANCE

DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81521-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	88.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81521-001-01	1 in 1 CARTON	05/01/2021
1		25 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2021

Labeler - Beautcella Inc. (928453625)