Indications and uses
Helps prevent sunburn.
SPF Rx - SPF 50 Spearmint Lip Balm
- Manufacturer
- Cal Pharma LLC | Health Specialty
- Effective date
- 2017-07-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:14:28
Label at a glance#
ProductSPF Rx - SPF 50 Spearmint Lip Balm
Active ingredientZINC, OCTINOXATE
Label structure7 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. 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 & early skin aging. To decrease this risk, regularly use a sunscreen with a 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....
Label contents#
Full prescribing information#
ACTIVE INGREDIENTS
Octinoxate 7.5%
Zinc 19%
Purpose
Sunscreen
USES
Helps prevent sunburn.
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.
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 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 & early skin aging. To decrease this risk, regularly use a sunscreen with a 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
INACTIVE INGREDIENTS
Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Olea Europaea (Olive) Fruit Oil, Flavor, Cannabis Sativa (Hemp) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Aloe Barbadensis Leaf Extract.
OTHER INFORMATION
Protect this product from excessive heat and direct sun.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55628-9585-0 | 2024-04-01 | C162847 | 48780-1 | d6a99b39-b6e2-a426-e053-dadaa90af4c2 | 821235a5-1a66-4459-add9-3dce13f9ff87 |
| 55628-9585-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b6e2-a426-e053-dadaa90af4c2 | 821235a5-1a66-4459-add9-3dce13f9ff87 |
Products#
Every source-derived product name is available through these pages.
- SPF Rx - SPF 50 Spearmint Lip Balm
- Octinoxate, Zinc
- ZINC
- OCTINOXATE
- SUNFLOWER OIL
- WHITE WAX
- OLIVE OIL
- CANNABIS SATIVA SEED OIL
- ROSEMARY
- TOCOPHEROL
- ALOE VERA LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55628-9585 | 55628-9585-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ZINC | J41CSQ7QDS | ACTIB |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| SUNFLOWER OIL | 3W1JG795YI | IACT |
| WHITE WAX | 7G1J5DA97F | IACT |
| OLIVE OIL | 6UYK2W1W1E | IACT |
| CANNABIS SATIVA SEED OIL | 69VJ1LPN1S | IACT |
| ROSEMARY | IJ67X351P9 | IACT |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | 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 |
|---|---|---|---|---|---|---|
| 150e8453-8cd9-089d-e063-6294a90ac738 | 821235a5-1a66-4459-add9-3dce13f9ff87 | 2024-04-01 | Warnings | 821235a5-1a66-4459-add9-3dce13f9ff87 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.