LUMENE CC COLOR CORRECTING SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM- octinoxate, titanium dioxide cream
Lumene Oy

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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LUMENE CC COLOR CORRECTING CREAM SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM

Drug Facts

Active ingredients

Octinoxate 4.0%

Titanium dioxide 0.8%

Purpose

sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

Do not ues

on damaged or broken skin.

Stop use and ask a doctor if

rash occurs.

When using this product,

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions

Apply liberally 15 minutes before sun exposure
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

Inacitve ingredients

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, ISODODECANE, DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, MAGNESIUM SULFATE, CETYL PEG/PPF-10/1 DIMETHICONE, HEXYL LAURATE, MICA, NYLON-12, PROPYLENE GLYCOL, LINGONBERRY (VACCINIUM VITIS-IDAEA) SEED OIL, CLOUDBERRY (RUBUS CHAMAEMORUS) SEED EXTRACT, CETEARYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, PERFLUOROOCTYL TRIETHOXYSILANE, ALUMINUM HYDROXIDE, PROPANEDIOL, PROPYLENE CARBONATE, METHICONE, ETHYLHEXYLGLYCERIN, GLYCERIN, ALUMINA, TRIETHOXYCAPRYLYLSILANE, SUNFLOWER (HELIANTHUS ANNUUS) SEED OIL, ROSEMARY (ROSMARINUS OFFICINALIS) LEAF EXTRACT, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES

Other information

Protect this product from excessive heat and direct sun.

Package Labeling:

Label

LUMENE CC COLOR CORRECTING SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67692-823
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MICA (UNII: V8A1AW0880)
NYLON-12 (UNII: 446U8J075B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LINGONBERRY SEED OIL (UNII: 44P1VFO6KM)
RUBUS CHAMAEMORUS WHOLE (UNII: O90MY5Z91V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSEMARY (UNII: IJ67X351P9)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67692-823-00	1 in 1 BOX	03/29/2017	04/03/2021
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/29/2017	04/03/2021

Labeler - Lumene Oy (401630129)

Revised: 10/2021

Document Id: cef770c1-c0c7-5877-e053-2995a90a658d

Set id: 4bdf6e1c-fe1a-7247-e054-00144ff88e88

Version: 3

Effective Time: 20211022

Lumene Oy