ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF 50 PLUS- homosalate, octisalate, titanium dioxide, zinc oxide cream 
ATOMY 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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ACTIVE INGREDIENTS

HOMOSALATE 7.50%
OCTISALATE 4.50%
TITANIUM DIOXIDE 2.20%
ZINC OXIDE 12.70%

INACTIVE INGREDIENTS

Aqua/Water/Eau, Cyclopentasiloxane, Dipropylene Glycol, Disiloxane, Lauryl Peg-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Propylheptyl Caprylate, Portulaca Oleracea Extract, Silica, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, 1,2-Hexanediol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Fragrance(Parfum), Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Adenosine, Tocopherol, Camellia Sinensis Leaf Extract, Melissa Officinalis Extract, Centella Asiatica Extract, Perilla Ocymoides Leaf Extract

PURPOSE

Sunscreen

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

DESCRIPTION

Directions:

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor
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

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

Other Information:
Protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF 50 PLUS 
homosalate, octisalate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.5 g  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.7 g  in 60 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.32 g  in 60 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7.62 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52257-1410-160 mL in 1 CARTON; Type 0: Not a Combination Product06/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2021
Labeler - ATOMY CO., LTD. (631154601)
Registrant - ATOMY CO., LTD. (631154601)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(52257-1410)

Revised: 7/2021
Document Id: 4455e2a3-b595-4387-bb19-9d63b55d53d5
Set id: ad0b9091-a990-45bf-93f4-d886be1bbffe
Version: 2
Effective Time: 20210716
 
ATOMY CO., LTD.