NIVEA SMOOTHNESS LIP CARE- avobenzone, octinoxate, 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

Octinoxate 6.0%

Octocrylene 1.8%

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, Hydrogenated Rapeseed
Oil, Beeswax, Cetyl Palmitate, Ricinus Communis (Castor) Seed Oil,
Polyglyceryl-3 Diisostearate, Butyrospermum Parkii (Shea) Butter,
Glycerin,Water, Simmondsia Chinensis (Jojoba) Seed Oil, Persea
Gratissima (Avocado) Oil, Aloe Barbadensis Leaf Juice, Fragrance, BHT

QUESTIONS

Questions? 1-800-227-4703

PRINCIPAL DISPLAY PANEL

NIVEA

Smoothness

Lip Care

and Sunscreen

broad spectrum SPF 15

All Day Nourishing Moisture

Mineral Oil Free

INGREDIENTS AND APPEARANCE

NIVEA SMOOTHNESS LIP CARE 
avobenzone, octinoxate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10356-818
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)
OCTYLDODECANOL (UNII: 461N1O614Y)
CASTOR OIL (UNII: D5340Y2I9G)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERIN (UNII: PDC6A3C0OX)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10356-818-25	4.8 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2015
2	NDC: 10356-818-41	2 in 1 BLISTER PACK	11/01/2015
2	NDC: 10356-818-25	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 not final	part352	11/01/2015

Labeler - Beiersdorf Inc (001177906)