Your browser does not support JavaScript! R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]
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R.E.M. DAY SPF 30 (avobenzone, octinoxate, and octisalate) lotion
[Erno Laszlo, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

Active Ingredients

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%

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, 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

  • 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 - 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57913-2834
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30 mg  in 1 mL
Octinoxate (Octinoxate) Octinoxate75 mg  in 1 mL
Octisalate (Octisalate) Octisalate50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Alkyl (C12-15) Benzoate 
Octyldodecyl Neopentanoate 
Butylene Glycol 
Glycerin 
Glyceryl Monostearate 
PEG-100 Stearate 
Yellow Wax 
Levomenol 
Ethylhexylglycerin 
Vitamin A Palmitate 
.Alpha.-Tocopherol Acetate 
Tetrahexyldecyl Ascorbate 
European Hazelnut Oil 
Sunflower Oil 
Avocado Oil 
Sesame Oil 
Hydnocarpus Kurzii Seed Oil 
Jojoba Oil 
Ginkgo 
Aloe Vera Leaf 
Asian Ginseng 
Centella Asiatica 
Echinacea Purpurea 
Hyaluronate Sodium 
Sodium Pyrrolidone Carboxylate 
Steareth-20 
Edetate Disodium 
Phenoxyethanol 
O-Cymen-5-Ol 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57913-2834-91 in 1 CARTON
190 mL in 1 BOTTLE
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(57913-2834), LABEL(57913-2834), PACK(57913-2834)

Revised: 4/2013
 
Erno Laszlo, Inc.

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