LUMINOUS INTENSIVE HAND TREATMENT SPF 25- avobenzone, octinoxate, and octisalate lotion 
Erno Laszlo, Inc.

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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Luminous Intensive Hand Treatment SPF 25

Drug Facts

Active Ingredients

Avobenzone 2%, Octinoxate 7.5%, Octisalate 5%

Purpose

Sunscreen

Uses

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 rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away.

Directions

Apply liberally 15 minutes before sun exposure

Inactive Ingredients

Water, Butyrospermum Parkii (Shea Butter), Octyldodecyl Neopentanoate, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Cyclomethicone, Steareth-20, Ceteth-20, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Taraktogenos Kurzii Seed Oil, Glycerin, Centella Asiatica Extract, Echinacea Purpurea Extract, Saxifraga Sarmentosa Extract, Vitis Vinifera (Grape) Fruit Extract, Morus Nigra Root Extract, Scutellaria Baicalensis Root Extract, Algae Extract, Fragrance, Carbomer, Phenoxyethanol, Isopropylparaben, Isobutylparaben, Butylparaben, Sodium Hydroxide.

Other information

Questions or comments?

Call toll free at 866-452-7956.

DISTRIBUTED IN U.S.A. BY ERNO LASZLO NEW YORK, NY 10001

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

ERNO
LASZLO

NEW YORK

LUMINOUS

INTENSIVE HAND TREATMENT
SPF 25

100mL e 3.3 fl.oz.

Principal Display Panel - 100 mL Tube Carton
LUMINOUS INTENSIVE HAND TREATMENT SPF 25 
avobenzone, octinoxate, and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57913-2525
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
STEARETH-20 (UNII: L0Q8IK9E08)  
CETETH-20 (UNII: I835H2IHHX)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
JOJOBA OIL (UNII: 724GKU717M)  
HYDNOCARPUS KURZII SEED OIL (UNII: N757YEZ18Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
WINE GRAPE (UNII: 3GOV20705G)  
MORUS NIGRA ROOT (UNII: 033456LFG1)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57913-2525-91 in 1 CARTON
1100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/10/2013
Labeler - Erno Laszlo, Inc. (098821031)
Establishment
NameAddressID/FEIBusiness Operations
Mana Products078870292MANUFACTURE(57913-2525) , LABEL(57913-2525) , PACK(57913-2525)

Revised: 4/2013
Document Id: fe301d66-7a2a-40ff-9f68-be31eefa5c3c
Set id: 6285f1f0-fd0c-4094-9f64-e9bf1bce8b85
Version: 1
Effective Time: 20130409
 
Erno Laszlo, Inc.