LUMENE BRIGHT NOW VITAMIN C BB SPF 20 SUNSCREEN BROAD SPECTRUM 02 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 Bright Now Vitamin C BB Cream SPF 20 Sunscreen Broad Spectrum 02 Medium

Drug Facts


ACTIVE INGREDIENTS

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), Citric Acid, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hippophae Rhamnoides (Sea Buckthorn) Oil, Iron Oxides, Laureth-7, Lecithin, Magnesium Ascorbyl Phosphate, Methyl Glucose Sesquistearate, MICA, PEG-20 Methyl Glucose Sesquistearate, PEG-8, Phenoxyethanol, Polyacrylamide, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rubus Chamaemorus (Cloudberry) Seed Oil, Sodium Hydroxide, Sorbic Acid, Sorbitan Stearate, Stearic Acid, Titanium Dioxide, Tocopherol, Triisostearin PEG-6 Esters, Water, Xanthan Gum

Product Labeling:

Label2Tube

LUMENE BRIGHT NOW VITAMIN C BB SPF 20 SUNSCREEN BROAD SPECTRUM 02 MEDIUM 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67692-149
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LAURETH-7 (UNII: Z95S6G8201)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
MICA (UNII: V8A1AW0880)  
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ROSEMARY (UNII: IJ67X351P9)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67692-149-001 in 1 CARTON09/04/201309/15/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/04/201309/15/2018
Labeler - LUMENE OY (401630129)
Registrant - LUMENE OY (401630129)
Establishment
NameAddressID/FEIBusiness Operations
LUMENE OY401630129manufacture(67692-149)

Revised: 11/2018
 
LUMENE OY