LUMENE TIME FREEZE TARGETED DARK SPOT CORRECTOR SUNSCREEN SPF 30- octinoxate, oxybenzone, 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 Time Freeze Targeted Dark Spot Corrector Sunscreen SPF 30

Lumene Time Freeze Targeted Dark Spot Corrector Sunscreen SPF 30


Active ingredients

Octinoxate 7.5%
Oxybenzone 6.0%
Titanium Dioxide 7.0%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

Skin Cancer / Skin Aging Alert:
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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:

Abies Picea (Spruce) Extract, Alanine, Alcohol Denat., C12-15 Alkyl Benzoate, Calcium Pantothenate, Caprylyl Glycol, Dimethylmethoxy Chromanyl Palmitate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldi Methyltaurate Copolymer, Magnesium Chloride, Magnesium Lactate, Octadecenedioic Acid, Papain, PEG-100 Stearate, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-3 Ricinoleate, Polysorbate 60, Potassium Lactate, Proline, Propanediol, Serine, Silica, Sodium Citrate, Sorbitan Stearate, Squalane, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Urea, Vaccinium Vitis-Idaea (Lingonberry) Fruit Extract, Water, Xanthan Gum

Lumene Time Freeze Targeted Dark Spot Corrector Sunscreen SPF 30 15ml (67692-339-00)

Lumene Label

LUMENE TIME FREEZE TARGETED DARK SPOT CORRECTOR SUNSCREEN SPF 30 
octinoxate, oxybenzone, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67692-339
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) OXYBENZONE60 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALANINE (UNII: OF5P57N2ZX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
MAGNESIUM LACTATE (UNII: MT6QI8324A)  
OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)  
PAPAIN (UNII: A236A06Y32)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
PROLINE (UNII: 9DLQ4CIU6V)  
PROPANEDIOL (UNII: 5965N8W85T)  
SERINE (UNII: 452VLY9402)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SQUALANE (UNII: GW89575KF9)  
STYRENE (UNII: 44LJ2U959V)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67692-339-001 in 1 CARTON08/21/201310/01/2016
115 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 finalpart35208/21/201310/01/2016
Labeler - LUMENE OY (401630129)
Establishment
NameAddressID/FEIBusiness Operations
LUMENE OY401630129manufacture(67692-339)

Revised: 9/2022
 
LUMENE OY