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LUMENE TIME FREEZE FIRMING DAY SPF 15

Dosage form: cream
Ingredients: AVOBENZONE 30mg in 1mL, OCTINOXATE 75mg in 1mL, OCTISALATE 40mg in 1mL, OXYBENZONE 50mg in 1mL
Labeler: LUMENE OY
NDC Code: 67692-361

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.

Lumene Time Freeze Firming Day Cream SPF 15

Lumene Time Freeze Firming Day Cream SPF 15

Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Octisalate 4.0%

Oxybenzone 5.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Starch Octenyl Succinate, Aqua, Ascorbic Acid, Ascorbyl Palmitate, Butylene Glycol, Butyrospermum Parkii (Shea Butter), C13-14 Isoparrafin, Calluna Vulgaris (Heather) Flower Extract, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin,Glyceryl Stearate, Heptyl Undecylenate, Hydrogenated Polyisobutene, Laureth-7, Parfum, PEG-100 Stearate, PEG-8, Phenoxyethanol, Pisum Sativum (Pea) Extract, Polyacrylamide, Propanediol, Silica Dimethyl Silylate, Sodium Hyaluronate, Sodium Hydroxide, Squalane, Tocopherol, Tocopheryl Acetate, Xanthum Gum.

Warnings

For external use only
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if irritation or rash develops and lasts.

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

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.

FIRMING DAY CREAM
SPF 15 - Medium protection, all skin types. Helps to maintain your skin's youthful suppleness and prevents the formation of fine lines. Protects against he harmful effects of the sun.

Firm and smooth skin with nature's ingredients;
Arctic heather protects the skin's elastin fibres.
Arbutin in the heather helps to prevent pigment changes.
Plant proteins activate the skin's collagen production.

Arctic heather
Wild heather survives even in the harsh conditions of arctic nature. Because of the healing properties heather is known to have been used in Finnish medicine. Due to the very short period of growth in the arctic, wild plants contain more intense levels of beneficial ingredients than plants that are cultivated or grown in other areas of the world.

TIME FREEZE
Firming Day Cream SPF 15
with Arctic Heather
SUNSCREEN

Lumene Time Freeze Firming Day Cream SPF 15

LUMENE TIME FREEZE FIRMING DAY SPF 15  
avobenzone, octinoxate, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67692-361
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE40 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
ALUMINUM STARCH OCTENYLSUCCINATE 
WATER 
ASCORBIC ACID 
ASCORBYL PALMITATE 
BUTYLENE GLYCOL 
SHEA BUTTER 
C13-14 ISOPARAFFIN 
CALLUNA VULGARIS FLOWERING TOP 
CETOSTEARYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
EDETATE SODIUM 
SHEA BUTTER 
XANTHAN GUM 
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
EDETATE DISODIUM 
ETHYLHEXYL PALMITATE 
GLYCERIN 
GLYCERYL STEARATE SE 
HEPTYL UNDECYLENATE 
POLYISOBUTYLENE (1100000 MW) 
LAURETH-7 
PEG-100 STEARATE 
PHENOXYETHANOL 
PEA 
POLYACRYLAMIDE (10000 MW) 
PROPANEDIOL 
SILICA DIMETHYL SILYLATE 
SODIUM HYDROXIDE 
SQUALANE 
TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:67692-361-0115 mL in 1 JAR
2NDC:67692-361-001 JAR (JAR) in 1 BOX
250 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/19/2010
Labeler - LUMENE OY (401630129)
Registrant - LUMENE OY (401630129)
Establishment
NameAddressID/FEIOperations
LUMENE OY401630129manufacture(67692-361)

Revised: 11/2012
 
LUMENE OY

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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