ATOMY BB SUNSCREEN- titanium dioxide, zinc oxide cream

ATOMY BB SUNSCREEN by

Drug Labeling and Warnings

ATOMY BB SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ATOMY CO., LTD., Kolmar Korea Co.,LTD. Gwanjeong 2 factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Titanium Dioxide 8.22%
Zinc Oxide 5.76%

INACTIVE INGREDIENTS

Aqua/Water/Eau, Butylene Glycol, Cyclopentasiloxane, Isopropyl Palmitate, Almond Oil, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Cyclohexasiloxane, Niacinamide, Talc, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Hydrogenated Poly(C6-14 Olefin), Magnesium Sulfate, Phytosqualane, Polyglyceryl-4 Isostearate, Purslane Extract, Iron Oxides, Triethoxycaprylylsilane, Disteardimonium Hectorite, Caprylyl Glycol, Glyceryl Caprylate, Trihydroxystearin, Aminopropyl Dimethicone, Polymethylsisesquioxane, Fragrance (Parfum), Alumina, Tea Leaf Extract, Silica Dimethyl Silylate, Tocopheryl Acetate, Silica, Dimethicone, Marshmallow Leaf/Root Extract, Borage Extract, Lemon Balm Leaf Extract, Rosemary 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.

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOMY BB SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52257-1430
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.22 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	5.76 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52257-1430-1	40 mL in 1 CARTON; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2023

Labeler - ATOMY CO., LTD. (631154601)

Registrant - ATOMY CO., LTD. (631154601)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong 2 factory		963271750	manufacture(52257-1430)