NIVEA RECOVERY MEDICATED LIP CARE- dimethicone, avobenzone, octinoxate, octocrylene stick

Nivea Recovery Medicated Lip Care by

Drug Labeling and Warnings

Nivea Recovery Medicated 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:

Dimethicone 1.2%

Avobenzone 2.5%

Octinoxate 6.0%

Octocrylene 1.8%

PURPOSE

Purpose:

Skin protectant

Sunscreen

INDICATIONS & USAGE

Uses helps prevent sunburn temporarily protects and helps relieve chapped or cracked lips 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, Hydrogenated
Rapeseed Oil, Beeswax, Cetyl Palmitate,
Butyrospermum Parkii (Shea) Butter,
Polyglyceryl-3 Diisostearate, Cetearyl
Alcohol, Bis-Diglyceryl Polyacyladipate-2,
Glycerin, Menthol, Simmondsia
Chinensis (Jojoba) Seed Oil, Persea
Gratissima (Avocado) Oil, Tocopheryl
Acetate, Panthenol,Water, Fragrance,
BHT, Iron Oxides.

QUESTIONS

Questions? 1-800-227-4703

PRINCIPAL DISPLAY PANEL

NIVEA

Recovery

Medicated Lip Repair

Lip Protectant and Sunscreen

broad spectrum SPF 15

all day nourishing moisture

mineral oil free

INGREDIENTS AND APPEARANCE

NIVEA RECOVERY MEDICATED LIP CARE 
dimethicone, avobenzone, octinoxate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10356-823
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.2 g  in 100 g
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
JOJOBA OIL (UNII: 724GKU717M)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
AVOCADO OIL (UNII: 6VNO72PFC1)
OCTYLDODECANOL (UNII: 461N1O614Y)
CASTOR OIL (UNII: D5340Y2I9G)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MENTHOL (UNII: L7T10EIP3A)
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10356-823-25	4.8 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/01/2015

Labeler - Beiersdorf Inc (001177906)