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

LUMENE CC COLOR CORRECTING SUNSCREEN BROAD SPECTRUM SPF 20 LIGHT by

Drug Labeling and Warnings

LUMENE CC COLOR CORRECTING SUNSCREEN BROAD SPECTRUM SPF 20 LIGHT by is a Otc medication manufactured, distributed, or labeled by Lumene Oy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67692-821
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67692-821-00	1 in 1 BOX	03/29/2017
1		30 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 not final	part352	03/29/2017

Labeler - Lumene Oy (401630129)