Indications and uses
* helps prevent sunburn
Vitamin E SPF15 Lip Balm
- Manufacturer
- Autumn Harp, Inc.
- Effective date
- 2023-01-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:16:33
Label at a glance#
ProductVitamin E SPF15 Lip Balm
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure12 sections
Label contents#
Full prescribing information#
WARNINGS AND PRECAUTIONS SECTION
Drug Facts
Active Ingredient
Avobenzone (2.0%, w.w)
Octisalate (5.0%, w.w)
Octocrylene (3.0%, w/w)
Purpose
Sunscreen
Sunscreen
Sunscreen
Uses
* helps prevent sunburn
Warnings
- For external use only
Do not use • on damaged or broken skin
OTC - WHEN USING SECTION
When using this product • keep out of eyes. Rinse with water to remove.
OTC - ASK DOCTOR SECTION
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.
INSTRUCTIONS FOR USE SECTION
Directions • Apply liberally 15 minutes before sun exposure. • 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 sun especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses. • reapply this product at least every 2 hours. • use water resistant sunscreen if swimming or sweating. • children under 6 months of age: ask a doctor.
DOSAGE & ADMINISTRATION SECTION
Other information • protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:
Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Hyrdogenated Coconut Oil, Euphorbia Cerifera (Candelilla) Wax, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Ammonium Glycyrrhizate, Triticum Vulgare (Wheat) Germ Oil, Vanilla Planifolia Fruit Extract (Vanilla), Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil
Principal Display Panel
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51514-0342-1 | 2023-12-28 | C162847 | 48780-1 | ba0f9c33-5bef-a910-e053-dadaa90a0b85 | Lip Care SPF 15 With Vitamin E |
| 51514-0342-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5bef-a910-e053-dadaa90a0b85 | Lip Care SPF 15 With Vitamin E |
Products#
Every source-derived product name is available through these pages.
- Vitamin E SPF15 Lip Balm
- Avobenzone, Octisalate, Octocrylene
- OCTISALATE
- OCTOCRYLENE
- CASTOR OIL
- YELLOW WAX
- OLIVE OIL
- COCONUT OIL
- ALKYL (C12-15) BENZOATE
- MEDIUM-CHAIN TRIGLYCERIDES
- .ALPHA.-TOCOPHEROL ACETATE
- AMMONIUM GLYCYRRHIZATE
- WHEAT GERM OIL
- VANILLA
- CALENDULA OFFICINALIS FLOWER
- ECHINACEA PURPUREA
- TOCOPHEROL
- SOYBEAN OIL
- CANDELILLA WAX
- AVOBENZONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51514-0342 | 51514-0342-1 |
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 |
|---|---|---|---|---|---|---|
| 298d8ca2-7142-0131-e063-6294a90a23c5 | 2ea1edb3-d8b3-1e8a-e054-00144ff88e88 | 2024-12-18 | Warnings | 2ea1edb3-d8b3-1e8a-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.