SPL UNCLASSIFIED SECTION
DRUG FACTS
Tropical Lip Balm
- Manufacturer
- Natural Star Labs, Ltd
- Effective date
- 2022-02-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:09:54
Label at a glance#
ProductTropical Lip Balm SPF 15
Active ingredientOXYBENZONE, OCTINOXATE
Label structure11 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:
Octinoxate 2.0%
Oxybenzone 4.5%
OTC - PURPOSE SECTION
Purpose
Octinoxate ........Sunscreen
Oxybenzone ......Sunscreen
INDICATIONS & USAGE SECTION
Uses: Helps prevent sunburn • Helps prevent and
temporarily protect dry, chapped or windburned lips.
WARNINGS SECTION
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun
increases your risk of skin cancer and early skin aging. This
product has been shown only to prevent sunburn, not skin
cancer or early aging.
OTHER SAFETY INFORMATION
For external use only
OTC - STOP USE SECTION
Stop use and ask a doctor: If rash or irritation develops
and lasts.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children: If swallowed, get medical
help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions: Apply liberally before sun exposure and as
needed.
Children under 6 months of age: Ask a doctor before use.
INACTIVE INGREDIENT SECTION
Inactive ingredients: Synthetic Beeswax, Helianthus
Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor)
Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Flavor,
Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PEEL HERE FOR DRUG FACTS Qxxxxxxx
Broad Spectrum SPF 15 Sunscreen
Tropical Lip Balm Net Wt. 0.15 oz (4.25g)
Dist. by: www. totallypromotional.com | Coldwater, OH 45828
SAFETY
SEAL
res
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52060-009-01 | 2022-02-03 | C162847 | 48780-1 | ba0f9c33-5c01-a910-e053-dadaa90a0b85 | Broad Spectrum SPF 15 Sunscreen Tropical Lip Balm |
| 52060-009-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5c01-a910-e053-dadaa90a0b85 | Broad Spectrum SPF 15 Sunscreen Tropical Lip Balm |
Products#
Every source-derived product name is available through these pages.
- Tropical Lip Balm SPF 15
- OCTINOXATE, OXYBENZONE
- OXYBENZONE
- OCTINOXATE
- YELLOW WAX
- SUNFLOWER OIL
- CASTOR OIL
- LANOLIN
- COCONUT OIL
- CORN OIL
- .ALPHA.-TOCOPHEROL
- BUTYLATED HYDROXYTOLUENE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52060-009 | 52060-009-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| SUNFLOWER OIL | 3W1JG795YI | IACT |
| CASTOR OIL | D5340Y2I9G | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| CORN OIL | 8470G57WFM | IACT |
| .ALPHA.-TOCOPHEROL | H4N855PNZ1 | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | 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 |
|---|---|---|---|---|---|---|
| f336d250-b0cd-4350-9ab1-2f4d2360b822 | bb643efd-9f55-430c-ae19-a1a0a79a52ca | 2022-08-03 | Warnings | bb643efd-9f55-430c-ae19-a1a0a79a52ca |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.