OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: Zinc Oxide 8.6%, Titanium Dioxide 6.5%
Protectif Untinted
- Manufacturer
- Derma Research Group Inc.
- Effective date
- 2024-06-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:13:37
Label at a glance#
ProductProtectif Untinted
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose: Sun Protectant
INDICATIONS & USAGE SECTION
Uses: Broad spectrum (Sun Protection Factor 50 /SPF 50).
WARNINGS SECTION
Warning: For external use only.
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
OTC - WHEN USING SECTION
When using this product avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
OTC - STOP USE SECTION
Discontinue use if rash or irritation develops or lasts. If irritation persists, consult a doctor.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of Children -if swallowed get medical help or contact Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82038-007-01 | Protectif Untinted | 100 g in 1 BOTTLE, PUMP | CREAM | 100 | 1 | |
| 82038-007-02 | Protectif Untinted | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 82038-007-03 | Protectif Untinted | 30 g in 1 BOTTLE, PUMP | CREAM | 30 | 1 | |
| 82038-007-04 | Protectif Untinted | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- 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
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82038-007 | 82038-007-01, 82038-007-02, 82038-007-03, 82038-007-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Protectif Untinted | ZINC OXIDE AND TITANIUM DIOXIDE | Derma Research Group Inc. | 1acd3f09-87f2-75e4-e063-6394a90a0cd9 | 2024-06-13 | Warnings | 82038-007-01 82038-007-02 82038-007-03 82038-007-04 82038-007 82038000701 82038000704 82038000702 82038000703 1acd3232-7d83-8f27-e063-6294a90a0fb4 1acd3f09-87f2-75e4-e063-6394a90a0cd9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.