Indications and uses
helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
IINFINITEK PARIS Broad Spectrum SPF 50 Mineral Face Lotion
- Manufacturer
- Prime Enterprises Inc.
- Effective date
- 2020-10-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:31:33
Label at a glance#
ProductInfinitek SPF 50 Mineral
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections
Dosage and administration
apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying 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 broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, es...
Label contents#
Full prescribing information#
Active ingredients
Titanium Dioxide 4 %
Zinc Oxide 4 %
Purpose
Sunscreen
Uses:
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
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 keep out of eyes. Rinse with water to remove.
OTC - ASK DOCTOR SECTION
Stop use and ask a doctor if rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- 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 broad spectrum SPF 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
- children under 6 months: Ask a doctor
Inactive ingredients:
Allantoin, Aloe Barbadensis Leaf Extract, Alumina, Bisabolol, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexyl Laurate, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Silica, Stearic Acid, Tocopheryl Acetate, Water
Other information
- protect this product from excessive heat and direct sun
- may stain some fabrics or surfaces
Questions or comments?
dermaswiss@dermaswiss.com
Derma Swiss Broad Spectrum SPF 50 SUNSCREEN Mineral Lotion
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0363-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2c46-0266-e053-dadaa90a7c1a | IINFINITEK PARIS Broad Spectrum SPF 50 Mineral Face Lotion |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0363-3 | InfinitekSPF 50 Mineral | 50 mL in 1 TUBE | LOTION | 50 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0363 | INFINITEK SPF 50 MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.] | 1 | Legacy NDC, 1 package rows | 20201014_b0b30e0f-c733-5cd2-e053-2a95a90ad8cc.zip |
Products#
Every source-derived product name is available through these pages.
- Infinitek SPF 50 Mineral
- Titanium Dioxide, Zinc Oxide
- EVENING PRIMROSE OIL
- PHYSALIS ANGULATA
- ROSA CANINA SEED
- TRIETHOXYCAPRYLYLSILANE
- PHENOXYETHANOL
- SILICON DIOXIDE
- CAMELLIA OLEIFERA LEAF
- POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
- .ALPHA.-TOCOPHEROL ACETATE
- ALLANTOIN
- ETHYLHEXYLGLYCERIN
- PEG-10 DIMETHICONE (600 CST)
- SHEA BUTTER
- WATER
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- DISTEARDIMONIUM HECTORITE
- GLYCERIN
- HEXYL LAURATE
- POLYGLYCERYL-4 ISOSTEARATE
- STEARIC ACID
- CYCLOMETHICONE 5
- ALUMINUM OXIDE
- TITANIUM DIOXIDE
- ZINC OXIDE
- ANACYSTIS NIDULANS EXTRACT
- FERRIC OXIDE RED
- LINSEED OIL
- MEDIUM-CHAIN TRIGLYCERIDES
- CUCUMBER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58443-0363 | 58443-0363-3 |
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 |
|---|---|---|---|---|---|---|
| b0b30e06-0a0d-6755-e053-2a95a90a685f | b0b30e0f-c733-5cd2-e053-2a95a90ad8cc | 2020-10-02 | Warnings | b0b30e06-0a0d-6755-e053-2a95a90a685f b0b30e0f-c733-5cd2-e053-2a95a90ad8cc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.