NIVEA SMOOTHNESS LIP CARE- avobenzone,octocrylene stick

Nivea Smoothness Lip Care by

Drug Labeling and Warnings

Nivea Smoothness Lip Care by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Avobenzone 2.5

Octocrylene 7%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & 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

WARNINGS

Warnings:

For external use only

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

Poison Control Center right away

DOSAGE & 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

INACTIVE INGREDIENT

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.

QUESTIONS

Questions? 1-800-227-4703

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

INGREDIENTS AND APPEARANCE

NIVEA SMOOTHNESS LIP CARE 
avobenzone,octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10356-819
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10356-819-25	4.8 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2021
2	NDC: 10356-819-41	2 in 1 BLISTER PACK	04/15/2021
2	NDC: 10356-819-25	4.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/15/2021

Labeler - Beiersdorf Inc (001177906)