360 by QUR Spanish lime lip balm

360 by QUR Spanish lime lip balm by

Drug Labeling and Warnings

360 by QUR Spanish lime 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 SPANISH LIME 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.

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360 by QUR Spanish lime lip balm

Drug Facts

Active ingredients

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:

360 BY QUR SPANISH LIME LIP BALM 
octinoxate, octocrylene, octisalate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61805-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	22 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61805-114-01	4 g in 1 CASE; Type 0: Not a Combination Product	02/24/2021	02/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/24/2021	02/24/2021

Labeler - Bath Concept Cosmetics (Dongguan) Co., Ltd (529623933)

Revised: 4/2021

Document Id: bee95b2c-c0cd-2fa4-e053-2995a90aba43

34390-5

Set id: be490fcd-faca-110a-e053-2a95a90a6303

Version: 2

Effective Time: 20210401

 

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