360 by QUR Watercress mint lip balm

360 by QUR Watercress mint lip balm by

Drug Labeling and Warnings

360 by QUR Watercress mint lip balm by is a Otc medication manufactured, distributed, or labeled by Bath Concept Cosmetics (Dongguan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

360 BY QUR WATERCRESS MINT LIP BALM- octinoxate, octocrylene, octisalate, avobenzone stick 
Bath Concept Cosmetics (Dongguan) Co., Ltd

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.

----------

360 by QUR Watercress mint lip balm

Drug Facts

Active ingredient

Octyl methoxycinnamate 5%, Octocrylene 3%, Octisalate 2.2%, Avobenzone 0.5%

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs.

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every two hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • For children under 6 months, consult a physician.

Other information

Protect this product from excessive heat and direct sunlight.

Inactive ingredients

Olea Europaea (Olive) Fruit Oil, Synthetic Wax, Hydrogenated Vegetable Oil, Cocos Nucifera (Coconut) Oil, Polybutene, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) wax, Bis-Diglyceryl Polyacyladipate-1, Butyrospermum Parkii (Shea Butter), Fragrance, Stevioside.

Package Labeling:

Bottle6

360 BY QUR WATERCRESS MINT LIP BALM 
octinoxate, octocrylene, octisalate, avobenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61805-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE22 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL (UNII: 6UYK2W1W1E)  
COCONUT OIL (UNII: Q9L0O73W7L)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CANDELILLA WAX (UNII: WL0328HX19)  
BIS-DIGLYCERYL POLYACYLADIPATE-1 (UNII: F6ZM55051M)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61805-116-014 g in 1 CASE; Type 0: Not a Combination Product02/24/202102/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/24/202102/24/2021
Labeler - Bath Concept Cosmetics (Dongguan) Co., Ltd (529623933)

Revised: 4/2021
 
Ba

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.