LUMENE BRIGHT NOW VITAMIN C DAY SPF 15 SUNSCREEN BROAD SPECTRUM- 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 Day Cream SPF 15 Sunscreen Broad Spectrum

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:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Ascorbic Acid, Ascorbyl Palmitate, Butylene Glycol, C13-14 Isoparaffin, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Chondrus Crispus (Carrageenan), Citric Acid, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Heptyl Undecylenate, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydrogenated Polyisobutene, Lactic Acid, Laureth-7, Lecithin, Magnesium Ascorbyl Phosphate, MICA, Panthenol, PEG-100 Stearate, PEG-8, Phenoxyethanol, Polyacrylamide, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rubus Chamaemorus (Cloudberry) Seed Extract, Rubus Chamaemorus (Cloudberry) Seed Oil, Serine, Sodium Chloride, Sodium Hydroxide, Sodium Lactate, Sorbitol, Squalane, TEA-Lactate, Titanium Dioxide, Tocopherol, Tocopheryl Acetate, Urea, Water, Xanthan Gum

Lumene Bright Now Vitamin C Day Cream SPF 15 Sunscreen Broad Spectrum 50ml (67692-141-00) | Lumene Bright Now Vitamin C Day Cream SPF 15 Sunscreen Broad Spectrum 15ml (67692-141-01) | Lumene Bright Now Vitamin C Day Cream SPF 15 Sunscreen Broad Spectrum 2ml (67692-141-02)

Vitamin C Day Cream 50 ml Vitamin C Day Cream 15 ml Vitamin C Day Cream 2 ml

Bright Now Vitamin C Day Cream SPF 15 50ml in Jar (67692-141-03)

Labeling for package code 03

LUMENE BRIGHT NOW VITAMIN C DAY SPF 15 SUNSCREEN BROAD SPECTRUM
octinoxate, oxybenzone, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67692-141
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
LACTIC ACID (UNII: 33X04XA5AT)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
MICA (UNII: V8A1AW0880)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
ROSEMARY (UNII: IJ67X351P9)
SERINE (UNII: 452VLY9402)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SORBITOL (UNII: 506T60A25R)
SQUALANE (UNII: GW89575KF9)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67692-141-00	1 in 1 CARTON	09/04/2013	02/01/2019
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC:67692-141-01	15 mL in 1 JAR; Type 0: Not a Combination Product	09/04/2013	04/21/2016
3	NDC:67692-141-02	2 mL in 1 PACKET; Type 0: Not a Combination Product	09/04/2013	10/22/2016
4	NDC:67692-141-03	1 in 1 BOX	09/04/2013	02/10/2018
4		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/04/2013	02/01/2019

Labeler - LUMENE OY (401630129)

Registrant - LUMENE OY (401630129)

Name	Address	ID/FEI	Business Operations
Establishment
LUMENE OY		401630129	manufacture(67692-141)

Revised: 9/2022

Document Id: e91fbee2-f77a-1154-e053-2995a90af6a1

Set id: 87756a3f-7f59-4658-971c-206bbe2975bc

Version: 5

Effective Time: 20220920

LUMENE OY