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
Medik8 Physical Sunscreen SPF 50
- Manufacturer
- Medik8 Limited
- Effective date
- 2024-03-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:10:25
Label at a glance#
ProductMedik8 Physical Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure7 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 Protections Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time i...
Label contents#
Full prescribing information#
Active ingredients
Zinc Oxide 12%
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
Do not use
- on damaged or broken skin
When using this product
- keep out of eyes. Rinse with water to remove
Stop use and ask a doctor
- if rash occurs
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 Protections Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: ask a doctor
Other information
Protect the product in this container from excessive heat and direct sun.
Inactive ingredients
Water, C12-15 Alkyl Benzoate, Coco-Caprylate, Propanediol, Butyloctyl Salicylate, Simmondsia Chinesis(Jojoba) Seed Oil, Glyceryl Behenate, Isopropyl Isostearate, Polyester-7, Squalane, Glyceryl Stearate, Neo-pentyl Glycol, Diheptanoate, Silica Silylate, Polyglyceryl-3 Ricinoleate, Isodecyl Salicylate, Dimethiconol/Propylsilesesquioxane/Silicate Crosspolymer, Trilaureth-4 Phosphate, Sodium Chloride, Allantoin, Bisabolol, Camellia Sinensis Leaf Extract, Glycerin, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Tocopherol Phenylpropanol, Caprylyl Glycol.
Package Labeling:
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 79988-001-60 | 2026-01-29 | C162847 | 48780-1 | 49896155-aa6a-586f-e063-e6dba90add90 | Medik8 Physical Sunscreen SPF 50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79988-001-60 | Medik8 Physical Sunscreen SPF 50 | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 79988-001-60 | Medik8 Physical Sunscreen SPF 50 | 60 mL in 1 TUBE | CREAM | 60 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Medik8 Physical Sunscreen SPF 50
- ZINC OXIDE
- WATER
- ALKYL (C12-15) BENZOATE
- COCO-CAPRYLATE
- PROPANEDIOL
- BUTYLOCTYL SALICYLATE
- JOJOBA OIL
- ISOPROPYL ISOSTEARATE
- POLYESTER-7
- SQUALANE
- GLYCERYL MONOSTEARATE
- NEOPENTYL GLYCOL
- POLYGLYCERYL-3 RICINOLEATE
- ISODECYL SALICYLATE
- TRILAURETH-4 PHOSPHATE
- SODIUM CHLORIDE
- ALLANTOIN
- LEVOMENOL
- GREEN TEA LEAF
- GLYCERIN
- HYALURONATE SODIUM
- VITIS VINIFERA SEED
- CAPRYLYL GLYCOL
- ZINC CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79988-001 | 79988-001-60 |
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 |
|---|---|---|---|---|---|---|
| 14cf316f-d344-b9aa-e063-6394a90a4447 | bb00b04d-2c23-6e38-e053-2a95a90a08f0 | 2024-03-29 | Warnings | 14cf316f-d344-b9aa-e063-6394a90a4447 bb00b04d-2c23-6e38-e053-2a95a90a08f0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.