Drug labels

Protectif Untinted

ZINC OXIDE AND TITANIUM DIOXIDE · Allure Labs · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
18aa2604-c8f0-ca04-e063-6294a90a1c25
ID
18aa2604-c8f1-ca04-e063-6294a90a1c25
Effective time
20240517
Version
1
SPL product data elements

Protectif Untinted Zinc Oxide and Titanium Dioxide TOCOPHEROL PEG/PPG-18/18 DIMETHICONE POLYGLYCERYL-4 ISOSTEARATE HEXYLENE GLYCOL DIMETHICONE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) HYDROXYTYROSOL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) PALMITOYL TETRAPEPTIDE-7 ASCORBIC ACID LECITHIN, SOYBEAN ARABICA COFFEE BEAN SODIUM FERROCYANIDE DECAHYDRATE POLYGONUM AVICULARE TOP SODIUM BENZOATE ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CYCLOMETHICONE 4 GLYCERIN STEARIC ACID DIPROPYLENE GLYCOL CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE POLYSORBATE 20 CAPRYLYL GLYCOL HYALURONATE SODIUM HEXYL LAURATE ALUMINUM HYDROXIDE PALMITOYL TRIPEPTIDE-1 WINE GRAPE CETEARYL OLIVATE TITANIUM DIOXIDE TITANIUM DIOXIDE ALKYL (C12-15) BENZOATE POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) DIMETHICONE/PEG-10/15 CROSSPOLYMER APPLE POLYSILICONE-15 POLYETHYLENE GLYCOL 400 BUTYLENE GLYCOL CYCLOMETHICONE 5 PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) SORBITAN OLIVATE ASCORBYL PALMITATE PHENOXYETHANOL ETHYLHEXYLGLYCERIN SODIUM CITRATE DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER GREEN TEA LEAF ZINC OXIDE ZINC OXIDE WATER SODIUM CHLORIDE .ALPHA.-TOCOPHEROL ACETATE BENZOIC ACID SILICA DIMETHYL SILYLATE PENTYLENE GLYCOL CITRIC ACID MONOHYDRATE ETHYLHEXYL PALMITATE CYCLOMETHICONE 6 TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE POTASSIUM SORBATE ECTOINE ISOMALT

Active ingredient
Active Ingredients: Zinc Oxide 8.6%, Titanium Dioxide 6.5%
Purpose
Purpose: Sun Protectant
Indications and 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 and 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

Package label principal display panel
Protectif Untinted
Harmonized identifiers (openFDA)
Application number
M020
Brand name
Protectif Untinted
Generic name
ZINC OXIDE AND TITANIUM DIOXIDE
Manufacturer name
Allure Labs
Product NDC
62742-4263
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
TITANIUM DIOXIDE, ZINC OXIDE
SPL ID
18aa2604-c8f1-ca04-e063-6294a90a1c25
SPL set ID
18aa2604-c8f0-ca04-e063-6294a90a1c25
Package NDC
62742-4263-1, 62742-4263-2, 62742-4263-3, 62742-4263-4
Is original packager
true
UNII
15FIX9V2JP, SOI2LOH54Z
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.