02 CUSHION SPF45 SUNSCREEN- sunscreen liquid

02 CUSHION SPF45 by

Drug Labeling and Warnings

02 CUSHION SPF45 by is a Otc medication manufactured, distributed, or labeled by COIZ CO LTD, OC QUEST INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Ethylhexyl Methoxycinnamate 7.0%

Ethylhexyl Salicylate 5.0%

Octocrylene 2.5%

Titanium Dioxide 13.5%

Zinc Oxide 5.0%

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 sun

Warnings

For external use only

Do not use

Do not use on damaged or broken skin

When using

When using this product keep out of eyes. Rinse with water to remove.

Stop use

Stop use and ask a doctor if rash occurs

Keep out of reach of children

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

Directions

▪ Using puff applicator, press down lightly onto presaturated cushion sponge to capture product. For maximum coverage, pat evenly over face. For light coverage, smooth over face using sweeping motion.
▪ Apply liberally and evenly 15 minutes before sun exposure ▪ Reapply ▪ After 80 minutes of swimming or
sweating ▪ Immediately after towel drying ▪ At least every 2 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 Spectrum SPF value 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 ▪ Use a water-resistant sunscreen if swimming or sweating.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Sodium chloride, Peg-9 diglycidyl ether/sodium hyaluronate crosspolymer, .Alpha.-Tocopherol acetate, Hamamelis virginiana flower water, Brown iron oxide, Edetate disodium anhydrous, Disteardimonium hectorite, Hexyl Laurate, Ferric oxide red, Cyclomethicone 5, Caprylic / capric / lauric triglyceride, Adenosine, Stearic acid, Glycerin, 1,2-Hexanediol, Aluminium oxide, Ferric oxide yellow, Centella asiatica, Cetyl PEG/PPG-10/1 Dimethicone, Mica, Triethoxycaprylylsilane, Water, Benzyl salicylate, Linalool, Polyhydroxystearic acid (2300 MW), PEG-10 Dimethicone, Oxygen, Hydroxyisohexyl 3-Cyclohexene carboxaldehyde, Dimethicone PEG-8 Laurate, Niacinamide.

Questions or Comments

Questions or Comments?
Call 1-855-460-6190 or visit www.oxygenceuticals.com

O2 CUSHION SPF 45 SUNSCREEN 30 mL (

72498-000-01)

INGREDIENTS AND APPEARANCE

02 CUSHION SPF45  SUNSCREEN
sunscreen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72498-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
NIACINAMIDE (UNII: 25X51I8RD4)
OXYGEN (UNII: S88TT14065)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HAMAMELIS VIRGINIANA FLOWER WATER (UNII: 222MYC9QUV)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
ADENOSINE (UNII: K72T3FS567)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
MICA (UNII: V8A1AW0880)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
ABIES KOREANA LEAF (UNII: QJK99UC36Q)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72498-000-01	1 in 1 BOX	06/30/2019
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/30/2019

Labeler - COIZ CO LTD (688382956)

Registrant - COIZ CO LTD (688382956)

Establishment
Name	Address	ID/FEI	Business Operations
OC QUEST INC		055996258	pack(72498-000)

Establishment
Name	Address	ID/FEI	Business Operations
COIZ CO LTD		688382956	manufacture(72498-000) , label(72498-000)