Nivea Smoothness Lip Care
- Manufacturer
- Beiersdorf Inc
- Effective date
- 2025-12-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:30:34
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients:
Avobenzone 2.5
Octocrylene 7%
OTC - PURPOSE SECTION
Purpose:
Sunscreen
INDICATIONS & USAGE SECTION
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 SECTION
Warnings:
For external use only
OTC - STOP USE 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 swallowed, get medical help or contact a
Poison Control Center right away
DOSAGE & ADMINISTRATION SECTION
For sunscreen use
- apply liberally at least 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every two hours
- 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 SpectrumSPFvalue 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-sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
INACTIVE INGREDIENT SECTION
Inactive ingredients:
Octyldodecanol, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Wax, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-3 Diisostearate, Hydrogenated Castor Oil, Glycerin, Tocopherol, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Water, Flavor.
OTC - QUESTIONS SECTION
Questions? 1-800-227-4703
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NIVEA
Smoothness Lip Care
Broad spectrum SPF 15
3X Care:
1. MOISTURE 2. REPAIR+ 3. SUNSCREEN
with Nourishing Oils, Vitamin C & E & ethically sourced Shea Butter*
+FOR DRY LIPS
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10356-819-25 | Nivea Smoothness Lip Care | 4.8 g in 1 TUBE | STICK | 4.8 | 5 | |
| 10356-819-41 | Nivea Smoothness Lip Care | 2 in 1 BLISTER PACK | STICK | 2 | 5 |
Products#
Every source-derived product name is available through these pages.
- Nivea Smoothness Lip Care
- Avobenzone,Octocrylene
- OCTYLDODECANOL
- CASTOR OIL
- GLYCERIN
- YELLOW WAX
- SHEA BUTTER
- WATER
- POLYGLYCERYL-3 DIISOSTEARATE
- AVOBENZONE
- OCTOCRYLENE
- TOCOPHEROL
- ASCORBYL PALMITATE
- SUNFLOWER OIL
- HYDROGENATED CASTOR OIL
- HELIANTHUS ANNUUS SEED WAX
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10356-819 | 10356-819-25, 10356-819-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTYLDODECANOL | 461N1O614Y | IACT |
| CASTOR OIL | D5340Y2I9G | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| SHEA BUTTER | K49155WL9Y | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYGLYCERYL-3 DIISOSTEARATE | 46P231IQV8 | IACT |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| ASCORBYL PALMITATE | QN83US2B0N | IACT |
| SUNFLOWER OIL | 3W1JG795YI | IACT |
| HYDROGENATED CASTOR OIL | ZF94AP8MEY | IACT |
| HELIANTHUS ANNUUS SEED WAX | 42DG15CHXV | 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 |
|---|---|---|---|---|---|---|
| Nivea Smoothness Lip Care | AVOBENZONE,OCTOCRYLENE | Beiersdorf Inc | c28e327d-ad39-9bd6-e053-2a95a90a04eb | 2025-12-31 | Warnings | 10356-819-41 10356-819-25 10356-819 10356081925 10356081941 474adb10-a17f-2c51-e063-6394a90a31f0 c28e327d-ad39-9bd6-e053-2a95a90a04eb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
