Drug Facts

Active Ingredients

Zinc Oxide 8.6 %

Titanium Dioxide 6.5 %

Purpose

Sun Protectant

Uses

Helps Prevent sunburn

Warning

For external use only.

Do not use on damaged or broken skin.

When using this product, avoid contect with eyes.If contect occurs, rinse throughly with water.

stop use

Discontinue use if rash or irritation develops or lasts. If irritation persists,consultant a doctor

Keep out of reach of children

If swallowed get medical help or contect poison control center right away.

Directions: Apply 15 minutes before sun exposure

Reapply at least every 2 hours 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 to 2 pm wear long sleeve shirts pants hats and sunglasses

Inactive Ingredients:

Water (Aqua), Cyclopentasiloxane,C12-15 Alkyl Benzoate,Dimethicone,Cyclotetrasiloxane,Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polysilicone-31,Glycerin,Aluminum Hydroxide,Stearic Acid,Dimethicone/PEG-10/15 Crosspolymer,Pyrus Malus (Apple) Fruit Extract,Sodium Chloride,Dipropylene Glycol,Sodium Citrate,Tocopherol,Dimethicone/Polyglycerin-3 Crosspolymer,

Dimethicone / Vinyl Dimethicone Crosspolymer,Tocopheryl Acetate,PEG/PPG-18/18 Dimethicone,Polyglyceryl-4 Isostearate,

Cetyl PEG/PPG-10/1 Dimethicone,Hexyl Laurate,Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinna mate, Cetearyl Olivate,

Sorbitan Olivate, Benzoic Acid,Ethylhexyl Palmitate,Silica Dimethyl Silylate, Butylene Glycol,Pentylene Glycol,

Sodium Hyaluronate, Cyclohexasiloxane,PEG-8, Ascorbyl Palmitate, Ascorbic Acid,Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone,Sodium Ferrocyanide Decahydrate,Hydroxytyrosol, Polygonum Aviculare Extract,Sodium Benzoate,

Potassium Sorbate,Alcohol,Lecithin,Ectoin,Cyclotetrapeptide-24 Aminocyclohexane Carboxylate,Carbomer,

Polysorbate 20,Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7,Vitis Vinifera (Grape) Fruit Cell Extract,

Isomalt,Camellia Sinensis Leaf Extract,Coffea Arabica (Coffee) Seed Extract, Citric Acid,Phenoxyethanol,Caprylyl Glycol,

Ethylhexylglycerin,Hexylene Glycol,Triethoxycaprylylsilane, Iron Oxides (CI 77491, CI 77492, CI 77499)

protectifdeeptint

PROTECTIF DEEP TINT
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82038-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.5 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.6 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIPROPYLENE GLYCOL (UNII: E107L85C40)
APPLE (UNII: B423VGH5S9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ISOMALT (UNII: S870P55O2W)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
HYDROXYTYROSOL (UNII: QEU0NE4O90)
BENZOIC ACID (UNII: 8SKN0B0MIM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ECTOINE (UNII: 7GXZ3858RY)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
VITIS VINIFERA STEM (UNII: K1Z31TDY7Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
TOCOPHEROL (UNII: R0ZB2556P8)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82038-002-02	1 in 1 CARTON	06/21/2022
1	NDC:82038-002-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	06/21/2022

Labeler - Derma Research Group Inc. (200108372)