Indications and uses
Helps prevent sunburn If uses as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Cream
- Manufacturer
- Oxygen Development LLC
- Effective date
- 2023-02-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:53:49
Label at a glance#
ProductCream
Active ingredientZINC OXIDE
Label structure15 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating. 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, especiall...
Storage and handling
Protect the product in this container from excessive heat and direct sun.
Label contents#
Full prescribing information#
Active Ingredient
Zinc Oxide 20%
Purpose
Sunscreen
Uses
Helps prevent sunburn
If uses 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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating.
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 10am to 2 pm
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: ask a doctor
Other information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes, Polyglyceryl-3 Polyricinoleate, Lecithin, Glycerin, Isostearic Acid, Polyhydroxystearic Acid, Silica, Glyceryl Caprylate, Damask Rose Flower Extract, Sunflower Seed Oil, Leuconostoc/Radish Root Ferment Filtrate, Coco-Caprylate/Caprate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Aloe Vera Leaf Juice, Maltodextrin, Orris Leaf Cell Extract, Indian Walnut Seed Oil, Algae Extract, Alexandrian Laurel Seed Oil, Pumpkin Seed Oil, Squalane, Xanthan Gum, Tocopherol, Bisabolol, Pomegranate Seed Oil, Creosote Bush Extract, Sodium Hyaluronate, Ascorbyl Palmitate.
Primary size 27ml
Secondary 27ml
Primary 68ml
Secondary 68ml
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-030-04 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6980-d83d-e063-dadaa90ab31f | KYPRIS POT OF SHADE HELIOTROPIC SPF 30 UVA+UVB SUNSCREEN PROTECTION SOLAIRE PRIMER |
| 61354-030-05 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6980-d83d-e063-dadaa90ab31f | KYPRIS POT OF SHADE HELIOTROPIC SPF 30 UVA+UVB SUNSCREEN PROTECTION SOLAIRE PRIMER |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-030-02 | Cream | 68 mg in 1 JAR | CREAM | 68 | 3 | |
| 61354-030-03 | Cream | 27 mg in 1 JAR | CREAM | 27 | 3 | |
| 61354-030-04 | Cream | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 61354-030-05 | Cream | 1 in 1 CARTON | CREAM | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cream
- Zinc Oxide
- POLYGLYCERYL-3 PENTARICINOLEATE
- WATER
- LECITHIN, SOYBEAN
- COCONUT ALKANES
- GLYCERIN
- MEDIUM-CHAIN TRIGLYCERIDES
- SODIUM CHLORIDE
- SUNFLOWER OIL
- GLYCERYL CAPRATE
- SILICON DIOXIDE
- POLYGLYCERYL-6 POLYRICINOLEATE
- ISOAMYL LAURATE
- ROSA DAMASCENA FLOWER
- ISOSTEARIC ACID
- POLYHYDROXYSTEARIC ACID (2300 MW)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-030 | 61354-030-02, 61354-030-04, 61354-030-03, 61354-030-05 |
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 |
|---|---|---|---|---|---|---|
| f45d8012-5c88-5d96-e053-2995a90a74b6 | bbefaa50-1071-7a45-e053-2995a90a7df3 | 2023-02-10 | Warnings | f45d8012-5c88-5d96-e053-2995a90a74b6 bbefaa50-1071-7a45-e053-2995a90a7df3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.