PROTECTIF FAIR TINT- zinc oxide and titanium dioxide cream

Protectif Fair Tint by

Drug Labeling and Warnings

Protectif Fair 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-t-butyl 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, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffee 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 FAIR TINT 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4262
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4262-2	1 in 1 CARTON	05/10/2024
1	NDC: 62742-4262-1	100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 62742-4262-4	1 in 1 CARTON	05/10/2024
2	NDC: 62742-4262-3	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	05/10/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4262)