Drug Facts

Active Ingredients

Avobenzone 2%, Octinoxate 7.5%, Octisalate 5%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

reapply: after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor

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

protect this product from excessive heat and direct sun

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57913-2525
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:57913-2525-9	1 in 1 CARTON
1		100 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/10/2013

Labeler - Erno Laszlo, Inc. (098821031)

Name	Address	ID/FEI	Business Operations
Establishment
Mana Products		078870292	MANUFACTURE(57913-2525) , LABEL(57913-2525) , PACK(57913-2525)

Luminous Intensive Hand Treatment SPF 25