PROTECTIF UNTINTED- zinc oxide and titanium dioxide cream

Protectif Untinted by

Drug Labeling and Warnings

Protectif Untinted 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-1011 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 Deca hydrate, Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate, Alcohol, Lecithin, Ectoin, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetra peptide-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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECTIF UNTINTED 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4263
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
TOCOPHEROL (UNII: R0ZB2556P8)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
HYDROXYTYROSOL (UNII: QEU0NE4O90)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
WINE GRAPE (UNII: 3GOV20705G)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
APPLE (UNII: B423VGH5S9)
POLYSILICONE-15 (UNII: F8DRP5BB29)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ECTOINE (UNII: 7GXZ3858RY)
ISOMALT (UNII: S870P55O2W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4263-2	1 in 1 CARTON	05/17/2024
1	NDC: 62742-4263-1	100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 62742-4263-4	1 in 1 CARTON	05/17/2024
2	NDC: 62742-4263-3	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	05/17/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4263)