CEILE SPF 45 FLUSH PROTECT- sunscreen 45 powder

Ceile SPF 45 flush PROTECT by

Drug Labeling and Warnings

Ceile SPF 45 flush PROTECT by is a Otc medication manufactured, distributed, or labeled by LÚE COSMETICS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 21.37%

Homosalate 5.0%

Titanium Dioxide 4.25%

Ethylhexyl Salicylate 3.0%

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 or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a docor if rash occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally15 minutes before sun exposure and as needed
reapply at least every 2 hours.

use a water resistant sunscreen if swimming or sweating
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

Inactive ingredients

Synthetic Fluorphlogopite, Mica, Boron Nitride, Zinc Stearate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Triethoxycaprylylsilane, Diisostearyl Malate, Ethylhexylglycerin, Caprylyl Glycol, Tocopherol, Red 7 Lake (CI 15850), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Yellow 5 Lake (CI 19140), Ultramarines (CI 77007)

Other Information

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

Questions?

1-866-860-0811

Purpose

Sunscreen

Keep out of reach of children

Keep out of reach of children

Principal Display Panel

INGREDIENTS AND APPEARANCE

CEILE SPF 45 FLUSH PROTECT 
sunscreen 45 powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83103-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mg  in 100 mg
ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	ETHYLHEXYL SALICYLATE	3 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	21.372 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.25 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
ZINC STEARATE (UNII: H92E6QA4FV)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
RED 7 (UNII: ECW0LZ41X8)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
YELLOW 5 (UNII: I753WB2F1M)
ULTRAMARINE VIOLET (UNII: 1YZ11D167R)
SILICON (UNII: Z4152N8IUI)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83103-1000-1	1 in 1 PACKAGE	01/30/2025
1		100 mg in 1 TRAY; 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	01/30/2025

Labeler - LÚE COSMETICS INC (105041170)