LUMENE BRIGHT NOW VITAMIN C MOISTURIZER- octinoxate, oxybenzone, octisalate, avobenzone 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 Moisturizer

Drug Facts

ACTIVE INGREDIENTS

Octinoxate 7.5%

Oxybenzone 5.0%   

Octisalate 4.0%

Avobenzone 3.0%

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:

Aqua (Water), Heptyl Undecylenate, Cetearyl Alcohol, Hydrogenated Polyisobutene, Propanediol, Glycerin, Squalane, Rubus Chamaemorus (Cloudberry) Seed Oil, Rubus Chamaemorus (Cloudberry) Seed Extract, Phenoxyethanol, Butylene Glycol, Cetearyl Glucoside, Tocopheryl Acetate, (CI 77891) Titanium Dioxide, Glyceryl Stearate, Mica, PEG-100 Stearate, Panthenol, Polyacrylamide, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Lecithin, C13-14 Isoparaffin, Disodium EDTA, Ethylhexylglycerin, Magnesium Ascorbyl Phospate, Hippophae Rhamnoides (Sea Buckthron) Oil, PEG-8, Carpylyl Glycol, Sodium Hydroxide, Laureth-7, Tocopherol, Lactic Acid, Serine, Sodium Lactate, Sorbitol, TEA-Lactate, Urea, Ascorbyl Palmitate, Sodium Chloride, Chondrus Crispus (Carrageenan), Ascorbic Acid, Citric Acid, Allontoin, Helianthus Annuus (Sunflower)Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Limonene, Linalool, Butylphenyl Methylpropional, Geraniol, Citral, Hexyl Cinnamal, Citronellol, Parfum (Fragrance)

Product Labeling:

image description

LUMENE BRIGHT NOW VITAMIN C MOISTURIZER 
octinoxate, oxybenzone, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67692-881
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SQUALANE (UNII: GW89575KF9)  
RUBUS CHAMAEMORUS SEED OIL (UNII: WH495F04LZ)  
RUBUS CHAMAEMORUS SEED (UNII: WEH5N5F4PW)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PANTHENOL (UNII: WV9CM0O67Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LAURETH-7 (UNII: Z95S6G8201)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
SERINE (UNII: 452VLY9402)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
SORBITOL (UNII: 506T60A25R)  
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)  
UREA (UNII: 8W8T17847W)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALLANTOIN (UNII: 344S277G0Z)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ROSEMARY (UNII: IJ67X351P9)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
GERANIOL (UNII: L837108USY)  
CITRAL (UNII: T7EU0O9VPP)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67692-881-001 in 1 CARTON10/06/201503/02/2019
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:67692-881-011 in 1 CARTON10/06/201510/10/2017
215 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/06/201503/02/2019
Labeler - Lumene Oy (401630129)

Revised: 11/2018
Document Id: 7b09812b-3bf1-569c-e053-2991aa0a48ed
Set id: a22de5a0-2363-4d94-ae9a-1984e60009d1
Version: 4
Effective Time: 20181119
 
Lumene Oy