OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Zinc Oxide 8.6 %
Titanium Dioxide 6.5 %
Protectif untinted
- 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 untinted
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
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, DimethiconelPolyglycerin-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 Hydroxyhydrocinnamate, Cetearyl Olivate,Sornitan 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,VitisVinifera(Grape)Fruit Cell Extract,Isomalt,Camellia Sinensis Leaf Extract,
Coffea Arabica (Coffee) Seed Extract,Citric Acid, Phenoxyethanol,Caprylyl Glycol,Ethylhexylglycerin,Hexylene Glycol
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 |
|---|---|---|---|---|---|
| 82038-004-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3eb8-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82038-004-01 | Protectif untinted | 100 g in 1 TUBE | CREAM | 100 | 1 | |
| 82038-004-02 | 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
- PEG/PPG-18/18 DIMETHICONE
- SILICA DIMETHYL SILYLATE
- PENTYLENE GLYCOL
- ALCOHOL
- ALUMINUM HYDROXIDE
- DIMETHICONE/PEG-10/15 CROSSPOLYMER
- SODIUM CITRATE
- WATER
- PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
- SORBITAN OLIVATE
- ASCORBYL PALMITATE
- APPLE
- SODIUM CHLORIDE
- HEXYL LAURATE
- CETEARYL OLIVATE
- ASCORBIC ACID
- SODIUM FERROCYANIDE DECAHYDRATE
- SODIUM BENZOATE
- HYDROXYTYROSOL
- BUTYLENE GLYCOL
- HYALURONATE SODIUM
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)
- CYCLOMETHICONE 6
- POLYGONUM AVICULARE TOP
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- POLYSORBATE 20
- PALMITOYL TETRAPEPTIDE-7
- CITRIC ACID MONOHYDRATE
- ISOMALT
- GREEN TEA LEAF
- CYCLOMETHICONE 5
- ALKYL (C12-15) BENZOATE
- ARABICA COFFEE BEAN
- CAPRYLYL GLYCOL
- ETHYLHEXYLGLYCERIN
- .ALPHA.-TOCOPHEROL ACETATE
- POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)
- DIPROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82038-004 | 82038-004-01, 82038-004-02 |
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 |
|---|---|---|---|---|---|---|
| e273cc47-7609-7f72-e053-2a95a90acdc5 | e273ccfc-3b2e-fdf4-e053-2a95a90ae4a3 | 2022-06-27 | Warnings | e273cc47-7609-7f72-e053-2a95a90acdc5 e273ccfc-3b2e-fdf4-e053-2a95a90ae4a3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.