LUMENE VITAMIN C BB ILLUMINATING ANTI-AGE BB SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM- octinoxate 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 Vitamin C+ BB Illuminating Anti-Age BB Cream Sunscreen Broad Spectrum SPF 20 Medium

Active Ingredient

Octinoxate 6%

Purpose

Sunscreen

Uses

Helps prevent sunburn

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 irritation or rash occurs.

Keep out of reach of children.

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

Directions

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

Inactive Ingredients

Alumina
Ascorbic Acid
Ascorbyl Palmitate
Boron Nitride
C13-14 Isoparaffin
Caprylyl Glycol
Chondrus Crispus (Carrageenan)
(CI 77891) Titanium Dioxide
Citric Acid
Cyclopentasiloxane
Dimethicone
Disodium EDTA
Fragrance
Glycerin
Iron Oxides
Laureth-7
Lecithin
Magnesium Ascorbyl Phosphate
Methyl Glucose Sesquistearate
PEG-20 Methyl Glucose Sesquistearate
PEG-8
Phenoxyethanol
Polyacrylamide
Rubus Chamaemorus (Cloudberry) Seed Oil
Silica
Sodium Hydroxide
Sorbic Acid
Sorbitan Stearate
Stearic Acid
Tocopherol
Triisostearin PEG-6 Esters
Water
Xanthan Gum

LUMENE OY

Lasikuja 2, 02780 Espoo Finland
Lumene U.S. Toll Free Number: 1-866-253-8619
www.lumene.com

Lumene Vitamin C+ BB Illuminating Anti-Age BB Cream Sunscreen Broad Spectrum SPF 20 Medium 50ml (67692-000-50)

LumeneBBCreamMedium

LUMENE VITAMIN C BB ILLUMINATING ANTI-AGE BB SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67692-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM OXIDE (UNII: LMI26O6933)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BORON NITRIDE (UNII: 2U4T60A6YD)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LAURETH-7 (UNII: Z95S6G8201)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
RUBUS CHAMAEMORUS SEED OIL (UNII: WH495F04LZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIISOSTEARIN (UNII: 71503RH8KG)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67692-000-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/08/2012	02/01/2016
2	NDC:67692-000-51	2 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package	08/08/2012	10/10/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/08/2012	10/10/2016

Labeler - Lumene Oy (401630129)

Registrant - Lumene Oy (401630129)

Name	Address	ID/FEI	Business Operations
Establishment
Lumene Oy		401630129	manufacture(67692-000)

Revised: 9/2022

Document Id: e91eac37-cb2e-3d02-e053-2995a90a4709

Set id: 5c695df2-d004-4dd8-9c71-cf6cdb7f034a

Version: 5

Effective Time: 20220920

Lumene Oy