OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Zinc Oxide 8.6 %
Titanium Dioxide 6.5 %
Protectif fair tint
- Manufacturer
- Derma Research Group Inc.
- Effective date
- 2022-06-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:49:59
Label at a glance#
ProductProtectif fair tint
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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
Do not use on damaged or broken skin.
OTC - WHEN USING SECTION
When using
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 a.m. - 2 p.m., 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 |
|---|---|---|---|---|---|
| 82038-003-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5d12-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82038-003-01 | Protectif fair tint | 100 g in 1 TUBE | CREAM | 100 | 1 | |
| 82038-003-02 | Protectif fair tint | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Protectif fair tint
- Zinc oxide and Titanium dioxide
- PALMITOYL TRIPEPTIDE-1
- PALMITOYL TETRAPEPTIDE-7
- SILICA DIMETHYL SILYLATE
- POLYGONUM AVICULARE TOP
- FERRIC OXIDE RED
- VITIS VINIFERA STEM
- ARABICA COFFEE BEAN
- CITRIC ACID MONOHYDRATE
- PHENOXYETHANOL
- PENTYLENE GLYCOL
- POLYSORBATE 20
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- DIMETHICONE/PEG-10/15 CROSSPOLYMER
- SODIUM CHLORIDE
- ASCORBYL PALMITATE
- SODIUM FERROCYANIDE DECAHYDRATE
- HYDROXYTYROSOL
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)
- SORBITAN OLIVATE
- WATER
- CYCLOMETHICONE 5
- CYCLOMETHICONE 4
- DIMETHICONE
- POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)
- ALUMINUM HYDROXIDE
- STEARIC ACID
- DIPROPYLENE GLYCOL
- SODIUM CITRATE
- PEG/PPG-18/18 DIMETHICONE
- ALKYL (C12-15) BENZOATE
- VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
- ISOMALT
- HEXYL LAURATE
- TOCOPHEROL
- .ALPHA.-TOCOPHEROL ACETATE
- POLYGLYCERYL-4 ISOSTEARATE
- HYALURONATE SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82038-003 | 82038-003-01, 82038-003-02 |
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 |
|---|---|---|---|---|---|---|
| e273a7ad-dad5-122f-e053-2a95a90a685f | e273a835-0ef0-6228-e053-2995a90afb04 | 2022-06-27 | Warnings | e273a7ad-dad5-122f-e053-2a95a90a685f e273a835-0ef0-6228-e053-2995a90afb04 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.