ATOMY LIP GLOW- octinoxate, octisalate gel

ATOMY LIP GLOW by

Drug Labeling and Warnings

ATOMY LIP GLOW by is a Otc medication manufactured, distributed, or labeled by ATOMY CO., LTD., Kolmar Korea Co.,Ltd. Bucheon Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients : ETHYLHEEXYL METHOXYCINNAMATE 6.0%, ETHYLHEXYL SALICYLATE 3.0%

INACTIVE INGREDIENT

Inactive Ingredients :

HYDROGENATED POLYISOBUTENE, DIISOSTEARYL MALATE, PHYTOSTERYL/ ISOSTEARYL/ CETYL/ STEARYL/ BEHENYL DIMER DILINOLEATE, PENTAERYTHRITYL TETRAISOSTEARATE, DIPHENYL DIMETHICONE, JOJOBA ESTERS, MICROCRYSTALLINE WAX, POLYETHYLENE, CAPRYLYL METHICONE, DIPENATAERYTHRITYL HEXAHYDROXYSTERATE/ HEXASTERATE/ HEXAROSINATE, TRIOCTYLDODECYL CITRATE, OCTYDODECANOL, GLYCERYL BEHENATE/ EICOSDIOATE, CERESIN, PHENOXYETHANOL, CAPRYLYL GLYCOL, FRAGRANCE, BUTYROSPERMUM PARK ( SHEA) BUTTER, GLYCERYL CZPRYLATE, RED 27, TITANIUM DIOXIDE, BHT, RED 6, RED 7, PERSEA GRATISSIMA ( AVOCADO) OIL, ROSA CANINA FRUIT OIL, ROSA DAMASCENA FLOWER OIL

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases 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.
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 reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DESCRIPTION

Directions: Apply Atomy Lip Glow highlighting the shape of your lips.

Uses: Helps prevent sunburn.
For sunscreen use:
Apply liberally 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Children under 6 months: Ask a doctor.
Other Information: Protect this product in container from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOMY LIP GLOW 
octinoxate, octisalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52257-1340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.19 g  in 3.3 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.09 g  in 3.3 g

Inactive Ingredients
Ingredient Name	Strength
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52257-1340-1	3.3 g in 1 CARTON; 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 not final	part352	11/01/2015

Labeler - ATOMY CO., LTD. (631154601)

Registrant - ATOMY CO., LTD. (631154601)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,Ltd. Bucheon Factory		689847167	manufacture(52257-1340)