LUMENE TIME FREEZE FIRMING DAY SPF 15- 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

Active Ingredients

Avobenzone 3.0%

Octinoxate 6.0%

Octisalate 2.0%

Octocrylene 2.7%

Warnings

For external use only.

If swallowed, get medical help. Avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts.

Keep Out Of Reach Of Children

Directions:

Apply to cleansed face and neck every morning.

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 15ml (67692-340-01)

LumeneDayCream

LUMENE TIME FREEZE FIRMING DAY SPF 15
avobenzone, octinoxate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67692-340
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
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)
LINGONBERRY (UNII: 0UNK9RZQ7X)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67692-340-01	15 mL in 1 JAR; Type 0: Not a Combination Product	11/07/2013	08/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/07/2013	08/10/2017

Labeler - LUMENE OY (401630129)

Registrant - LUMENE OY (401630129)

Name	Address	ID/FEI	Business Operations
Establishment
LUMENE OY		401630129	manufacture(67692-340)

Revised: 9/2022

Document Id: e9311ced-6359-ef24-e053-2a95a90adc55

Set id: 3f74bb53-536a-437f-8969-a35eb632e2aa

Version: 4

Effective Time: 20220921

LUMENE OY