PROTECTIF DEEP TINT- zinc oxide and titanium dioxide cream

Protectif Deep Tint by

Drug Labeling and Warnings

Protectif Deep Tint by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide 8.6%,

Titanium Dioxide 6.5%

PURPOSE

Purpose: Sun Protectant

INDICATIONS & USAGE

Uses: Broad spectrum (Sun Protection Factor 50 /SPF 50).

WARNINGS

Warning: For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product, avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children - if swallowed get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions: Adults and Children over 6 months of age: Apply generously and evenly 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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses.

OTHER SAFETY INFORMATION

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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT

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-tbutyl Hydroxyhydrocinnamate, 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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECTIF DEEP TINT 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4261
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDROXYTYROSOL (UNII: QEU0NE4O90)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
ISOMALT (UNII: S870P55O2W)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
STEARIC ACID (UNII: 4ELV7Z65AP)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
ECTOINE (UNII: 7GXZ3858RY)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
APPLE (UNII: B423VGH5S9)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
WINE GRAPE (UNII: 3GOV20705G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4261-2	1 in 1 CARTON	05/09/2024
1	NDC: 62742-4261-1	100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 62742-4261-4	1 in 1 CARTON	05/09/2024
2	NDC: 62742-4261-3	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/09/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4261)