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
Sky and Sol SPF25 Lip Balm
- Manufacturer
- Guangzhou Fantesy Biotechnology Co.,Ltd
- Effective date
- 2026-01-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:31:10
Label at a glance#
ProductSky and Sol SPF25 Lip Balm
Active ingredientZINC OXIDE
Label structure10 sections
Dosage and administration
Directions ■ shake well before use apply liberally 15 minutes before sun exposure ■ reapply: ●after 80 minutes of swimming or sweating ●immediately after towel drying ●at least every 2 hours ■ children after 6 months of age: ask a doctor
Storage and handling
Protect the product in this container from excessive heat and direct sun.
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Non-Nano Zinc Oxide 15%
OTC - PURPOSE SECTION
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
① For external use only.
② When using this product keep out of eyes. Rinse with water to remove.
③ Stop use and ask a doctor if rash occurs.
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
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
Directions
■ shake well before use apply liberally 15 minutes before sun exposure
■ reapply: ●after 80 minutes of swimming or sweating ●immediately after towel drying ●at least every 2 hours
■ children after 6 months of age: ask a doctor
Other information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis)，
Camellia Sinensis (Green Tea) Leaf Extract
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83447-009-01 | Sky and Sol SPF25 Lip Balm | 9 g in 1 BOX | PASTE | 9 | 2 |
Products#
Every source-derived product name is available through these pages.
- Sky and Sol SPF25 Lip Balm
- BEEF TALLOW
- OLIVE OIL
- YELLOW WAX
- SHEA BUTTER
- ZINC OXIDE
- PROPOLIS WAX
- GREEN TEA LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83447-009 | 83447-009-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BEEF TALLOW | 98HPY76U4W | IACT |
| OLIVE OIL | 6UYK2W1W1E | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| SHEA BUTTER | K49155WL9Y | IACT |
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| PROPOLIS WAX | 6Y8XYV2NOF | IACT |
| GREEN TEA LEAF | W2ZU1RY8B0 | IACT |
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 |
|---|---|---|---|---|---|---|
| Sky and Sol SPF25 Lip Balm | SKY AND SOL SPF25 LIP BALM | Guangzhou Fantesy Biotechnology Co.,Ltd | 1f37c0c3-6443-60a3-e063-6394a90a596f | 2026-01-05 | Warnings | 83447-009-01 83447-009 83447000901 479ee2c0-168e-f6f6-e063-6294a90a5d22 1f37c0c3-6443-60a3-e063-6394a90a596f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.