Nivea Smoothness Lip Care

Nivea Smoothness Lip Care
SPL v5
SPL
SPL Set ID c28e327d-ad39-9bd6-e053-2a95a90a04eb
Route
TOPICAL
Published
Effective Date 2024-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.5 g) Octocrylene (7 g)
Inactive Ingredients
Octyldodecanol Castor Oil Glycerin Yellow Wax Shea Butter Water Polyglyceryl-3 Diisostearate Tocopherol Ascorbyl Palmitate Sunflower Oil Hydrogenated Castor Oil Helianthus Annuus Seed Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-15
Description

Active ingredients: Avobenzone 2.5 Octocrylene 7%

Medication Information

Warnings and Precautions

Warnings:

For external use only

Indications and Usage

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

Dosage and Administration

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
Description

Active ingredients: Avobenzone 2.5 Octocrylene 7%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a



Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 51727-6

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.

Section 51945-4

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

Section 53413-1

Questions? 1-800-227-4703

Section 55105-1

Purpose:

Sunscreen

Section 55106-9

Active ingredients:

Avobenzone 2.5

Octocrylene 7%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings:

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a



Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions? 1-800-227-4703

Section 55105-1 (55105-1)

Purpose:

Sunscreen

Section 55106-9 (55106-9)

Active ingredients:

Avobenzone 2.5

Octocrylene 7%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:02.232527 · Updated: 2026-03-14T23:12:10.193103