DR.ORACLE AIR FIT DEFENSE SOOTHING SUNSCREEN- homosalate, octyl salicylate, titanium dioxide, zinc oxide cream

Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN by

Drug Labeling and Warnings

Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Oracle Cosmetic Co., Ltd., Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 7.5 %

Octyl salicylate 4.5 %

Titanium dioxide 2.2 %

Zinc oxide 12.7 %

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

Do not use

on damaged skin 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

Keep out of reach of children

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

Directions

■ apply liberally 15 minutes before sun exposure. 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
■ children under 6 months of age: Ask a doctor
■ reapply at least every 2 hours
■ use a water-resistant sunscreen if swimming or sweating

Other information

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, Cyclopentasiloxane, Coco-Caprylate/Caprate, Dipropylene Glycol, Lauryl PEG-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Butyloctyl Salicylate, Methyl Methacrylate Crosspolymer, Dist- eardimonium Hectorite, Magnesium Sulfate, Vinyl Dimethicone/Methicone Silsesquioxane Cross- polymer, Dimethicone, 1,2-Hexanediol,Triethoxycaprylylsilane, Stearic Acid, Aluminum Hydroxide, Sorbitan Caprylate, Dimethicone/PEG- 10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Sodium Citrate, Tocopherol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.ORACLE AIR FIT DEFENSE SOOTHING SUNSCREEN 
homosalate, octyl salicylate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71883-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.35 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.1 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.75 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TOCOPHEROL (UNII: R0ZB2556P8)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71883-050-02	1 in 1 BOX	09/26/2024
1	NDC: 71883-050-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/26/2024

Labeler - Oracle Cosmetic Co., Ltd. (688258270)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(71883-050)