OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Zinc Oxide 8.6 %
Titanium Dioxide 6.5 %
Protectif deep tint
- Manufacturer
- Derma Research Group Inc.
- Effective date
- 2022-06-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:49:58
Label at a glance#
ProductProtectif deep tint
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose
Sun Protectant
INDICATIONS & USAGE SECTION
Uses
Helps Prevent sunburn
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 contect with eyes.If contect occurs, rinse throughly with water.
OTC - STOP USE SECTION
stop use
Discontinue use if rash or irritation develops or lasts. If irritation persists,consultant a doctor
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
If swallowed get medical help or contect poison control center right away.
DOSAGE & ADMINISTRATION SECTION
Directions: Apply 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 other sun protection measures including limit time in the sun especially from 10 am to 2 pm wear long sleeve shirts pants hats and sunglasses
OTHER SAFETY INFORMATION
NA
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-10/1 Dimethicone,Hexyl Laurate,Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinna mate, 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)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82038-002-02 | 2024-01-30 | C162847 | 48780-1 | 1030e364-fcae-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82038-002-01 | Protectif deep tint | 100 g in 1 TUBE | CREAM | 100 | 1 | |
| 82038-002-02 | Protectif deep tint | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Protectif deep tint
- Zinc oxide and Titanium dioxide
- DIPROPYLENE GLYCOL
- APPLE
- ETHYLHEXYLGLYCERIN
- CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE
- LECITHIN, SOYBEAN
- FERROSOFERRIC OXIDE
- VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
- .ALPHA.-TOCOPHEROL ACETATE
- PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
- SILICA DIMETHYL SILYLATE
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)
- POLYETHYLENE GLYCOL 400
- ALCOHOL
- POLYSORBATE 20
- SODIUM CHLORIDE
- SORBITAN OLIVATE
- ISOMALT
- GREEN TEA LEAF
- ARABICA COFFEE BEAN
- TRIETHOXYCAPRYLYLSILANE
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- DIMETHICONE
- CYCLOMETHICONE 4
- HYDROXYTYROSOL
- BENZOIC ACID
- HYALURONATE SODIUM
- CYCLOMETHICONE 6
- ASCORBYL PALMITATE
- SODIUM FERROCYANIDE DECAHYDRATE
- POTASSIUM SORBATE
- CETEARYL OLIVATE
- CITRIC ACID MONOHYDRATE
- PHENOXYETHANOL
- PEG/PPG-18/18 DIMETHICONE
- POLYGLYCERYL-4 ISOSTEARATE
- HEXYL LAURATE
- ECTOINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82038-002 | 82038-002-01, 82038-002-02 |
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 |
|---|---|---|---|---|---|---|
| e24b42d2-aa50-a0f9-e053-2a95a90aa1b8 | e24b5194-0716-4de2-e053-2a95a90adb5f | 2022-06-25 | Warnings | e24b42d2-aa50-a0f9-e053-2a95a90aa1b8 e24b5194-0716-4de2-e053-2a95a90adb5f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.