R.E.M. Day SPF 30: Package Insert and Label Information

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.

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
(click image for full-size original)
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 (Avobenzone) Avobenzone 30 mg in 1 mL
Octinoxate (Octinoxate) Octinoxate 75 mg in 1 mL
Octisalate (Octisalate) Octisalate 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Multilevel Packaging
1 NDC:57913-2834-9 1 BOTTLE in 1 CARTON contains a BOTTLE
1 90 mL in 1 BOTTLE This package is contained within the CARTON (57913-2834-9)
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 Operations
Mana Products 078870292 MANUFACTURE (57913-2834), LABEL (57913-2834), PACK (57913-2834)

Revised: 04/2013 Erno Laszlo, Inc.

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