NIVEA SMOOTHNESS LIP CARE- avobenzone, octinoxate, octocrylene stick 
Beiersdorf Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NIVEA Smoothness Lip Care

Active ingredients:

Avobenzone 2.5

Octinoxate 6.0%

Octocrylene 1.8%

Purpose:

Sunscreen

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:

For external use only

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away

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 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? 1-800-227-4703

smoothnessmofreecardNIVEA

Smoothness

Lip Care

and Sunscreen

broad spectrum SPF 15

All Day Nourishing Moisture

Mineral Oil Free

NIVEA SMOOTHNESS LIP CARE 
avobenzone, octinoxate, octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10356-818
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
JOJOBA OIL (UNII: 724GKU717M)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10356-818-254.8 g in 1 TUBE; Type 0: Not a Combination Product11/01/2015
2NDC:10356-818-412 in 1 BLISTER PACK11/01/2015
2NDC:10356-818-254.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/201512/31/2022
Labeler - Beiersdorf Inc (001177906)

Revised: 5/2021
 
Beiersdorf Inc