LUMENE TIME FREEZE FIRMING DAY SPF 15 SUNSCREEN BROAD SPECTRUM- avobenzone, octinoxate, octisalate, octocrylene 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 Firming Day Cream SPF 15 Sunscreen Broad Spectrum

Lumene Time Freeze Firming Day Cream SPF 15 Sunscreen Broad Spectrum


ACTIVE INGREDIENTS

Avobenzone 3.0%
Octinoxate 6.0%
Octisalate 2.0%
Octocrylene 2.7%

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:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aluminum Starch Octenyl Succinate, Ascorbic Acid, Ascorbyl Palmitate, Butylene Glycol, Butyrospermum Parkii (Shea Butter), C13-14 Isoparaffin, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Crocus Chrysanthus Bulb Extract, Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Stearate, Gum Arabic, Heptyl Undecylenate, Hydrogenated Polyisobutene, Iron Oxides, Laureth-7, PEG-100 Stearate, PEG-8, Phenoxyethanol, Polyacrylamide, Propanediol, Silica dimethyl silylate, Sodium Hyaluronate, Sodium Hydroxide, Squalane, Styrene/Acrylates Copolymer, Tocopherol, Tocopheryl Acetate, Vaccinium Vitis-Idaea (Lingonberry) Fruit Extract, Water, Xanthan Gum

Lumene Time Freeze Firming Day Cream SPF 15 Sunscreen Broad Spectrum 50ml (67692-332-00)

Time Freeze 50 ml Label

LUMENE TIME FREEZE FIRMING DAY SPF 15 SUNSCREEN BROAD SPECTRUM 
avobenzone, octinoxate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67692-332
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SHEA BUTTER (UNII: K49155WL9Y)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ACACIA (UNII: 5C5403N26O)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
LAURETH-7 (UNII: Z95S6G8201)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPANEDIOL (UNII: 5965N8W85T)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
STYRENE (UNII: 44LJ2U959V)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67692-332-001 in 1 CARTON09/04/201310/29/2017
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/04/201310/29/2017
Labeler - LUMENE OY (401630129)
Registrant - LUMENE OY (401630129)
Establishment
NameAddressID/FEIBusiness Operations
LUMENE OY401630129manufacture(67692-332)

Revised: 9/2022
 
LUMENE OY