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#

ProductNivea Smoothness Lip Care
Active ingredientAVOBENZONE, OCTOCRYLENE
Label structure10 sections

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

smoothnesscardwifsmoothnesscardwif

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10356-819-25Nivea Smoothness Lip Care4.8 g in 1 TUBESTICK4.85
10356-819-41Nivea Smoothness Lip Care2 in 1 BLISTER PACKSTICK25

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10356-81910356-819-25, 10356-819-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nivea Smoothness Lip CareAVOBENZONE,OCTOCRYLENEBeiersdorf Incc28e327d-ad39-9bd6-e053-2a95a90a04eb2025-12-31WarningsExact identifier
ndc (package): 10356-819-41
ndc (package): 10356-819-25
ndc (product): 10356-819
ndc11 (package): 10356081925
ndc11 (package): 10356081941
spl id: 474adb10-a17f-2c51-e063-6394a90a31f0
spl set id: c28e327d-ad39-9bd6-e053-2a95a90a04eb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.