Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT: Zinc Oxide 9%
OTC - PURPOSE SECTION
PURPOSE:Sunscreen
PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen
- Manufacturer
- Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
- Effective date
- 2024-09-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:22:12
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
DIRECTIONS: • Apply liberally 15 minutes before sun exposure • Use a water resistant product if swimming or sweating. • Reapply at least every 2 hours • Children under 6 months: Ask a doctor • 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 - 2 pm • Wear long-sleeved shirts, pants, hats, and sunglasses
Warnings
WARNINGS SECTION
WARNINGS: For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
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. Apply liberally 15 minutes before sun exposure.
Other Label Information
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: Butylene Glycol, Caffeine, Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Hydrogen Dimethicone, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomyces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – 15 g Bottle Label Proceuticals PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen broad spectrum spf 20 with gentle zinc oxide, peptides & botanical blend net wt. 0.5 oz. / 15 g Graphic-Untitled
Label Images#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7dea7767-9f52-b60a-5435-33cb9cc28bae | Product name | 4 | 20250124 |
| 6338270f-96cb-0ecb-6fbb-0a9bc78001f4 | Product name | 7 | 20250116 |
| 0ca83774-3f79-b837-5d6f-c210102f3bc8 | Product name | 6 | 20250114 |
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 2dc76302-91c0-4c35-ad78-99adfb049c4b | Product name | 1 | 20200603 |
| e6065d4b-5ae1-476f-a40e-f2851cbb5d2b | Product name | 2 | 20180221 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 332e86c3-7875-ca6e-f934-2206d2b31996 | Product name | 1 | 20140508 |
| 56625fcc-aa34-9d30-d0e9-1c1beb37ea21 | Product name | 1 | 20140508 |
| 7dfac40f-a405-cd2e-7c06-3059ec0e1092 | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| d223c173-c39b-d764-47d4-d671d3088815 | Product name | 1 | 20140508 |
| e01133ad-4dcd-c7f3-454b-2ff569ee160a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-236-05 | PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen | 15 g in 1 BOTTLE, PUMP | CREAM | 15 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-236 | PROCEUTICALS PRIVATE LABEL BY TIZO EYE REPAIR NON-TINTED MINERAL SUNSCREEN (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 2 | Current NDC, 1 package rows | 20240929_231af290-99ee-e94d-e063-6394a90a0bef.zip |
Products#
- PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-236 | 58892-236-05 |
Ingredients#
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT: Zinc Oxide 9%
OTC - PURPOSE SECTION
PURPOSE:Sunscreen
INDICATIONS & USAGE SECTION
DIRECTIONS: • Apply liberally 15 minutes before sun exposure • Use a water resistant product if swimming or sweating. • Reapply at least every 2 hours • Children under 6 months: Ask a doctor • 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 - 2 pm • Wear long-sleeved shirts, pants, hats, and sunglasses
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: Butylene Glycol, Caffeine, Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Hydrogen Dimethicone, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomyces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water
OTHER SAFETY INFORMATION
OTHER INFORMATION: • Protect this product from excessive heat and direct sun
WARNINGS SECTION
WARNINGS: For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
DOSAGE & ADMINISTRATION SECTION
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. Apply liberally 15 minutes before sun exposure.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – 15 g Bottle Label Proceuticals PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen broad spectrum spf 20 with gentle zinc oxide, peptides & botanical blend net wt. 0.5 oz. / 15 g Graphic-Untitled