R.E.M. DAY SPF 30- 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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R.E.M. Day SPF 30

Drug Facts

Active Ingredients

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%

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, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Beeswax, Bisabolol, Ethylhexylglycerin, Hydroxyethylcellulose, Lecithin, Micrococcus Lysate, Retinyl Palmitate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Corylus Avellana (Hazel) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Sesamum Indicum (Sesame) Seed Oil, Taraktogenos Kurzii Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Ginkgo Biloba Leaf Extract, Aloe Barbadensis Leaf Extract, Panax Ginseng Root Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Algae Extract, Plankton Extract, Sodium Hyaluronate, Sodium PCA, Steareth –20, Disodium EDTA, Phenoxyethanol, O-Cymen-5-Ol, Fragrance.

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 - 90 mL Bottle Carton

ERNO
LASZLO

NEW YORK

R.E.M.

DAY LOTION SPF 30

90mL e 3.0 fl.oz.

Principal Display Panel - 90 mL Bottle Carton
R.E.M. DAY SPF 30 
avobenzone, octinoxate, and octisalate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57913-2834
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 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
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Levomenol (UNII: 24WE03BX2T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
European Hazelnut Oil (UNII: 8RQ2839AVG)  
Sunflower Oil (UNII: 3W1JG795YI)  
Avocado Oil (UNII: 6VNO72PFC1)  
Sesame Oil (UNII: QX10HYY4QV)  
Hydnocarpus Kurzii Seed Oil (UNII: N757YEZ18Q)  
Jojoba Oil (UNII: 724GKU717M)  
Ginkgo (UNII: 19FUJ2C58T)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Asian Ginseng (UNII: CUQ3A77YXI)  
Centella Asiatica (UNII: 7M867G6T1U)  
Echinacea Purpurea (UNII: QI7G114Y98)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Steareth-20 (UNII: L0Q8IK9E08)  
Edetate Disodium (UNII: 7FLD91C86K)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
O-Cymen-5-Ol (UNII: H41B6Q1I9L)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57913-2834-9 1 in 1 CARTON
1 90 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/10/2013
Labeler - Erno Laszlo, Inc. (098821031)
Establishment
Name Address ID/FEI Business Operations
Mana Products 078870292 MANUFACTURE(57913-2834) , LABEL(57913-2834) , PACK(57913-2834)

Revised: 4/2013
Document Id: 6734af15-1a64-4b4b-a8f3-d707d871511f
Set id: 2a7dfdf8-ed0d-4d30-93e1-b88c1a3de75c
Version: 1
Effective Time: 20130410
 
Erno Laszlo, Inc.