OIL-CONTROL DAY SPF 15- avobenzone and octinoxate 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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Oil-Control Day SPF 15

Drug Facts

Active Ingredients

Avobenzone 3.0%, Octinoxate 7.5%

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, Butylene Glycol, Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Saccharide Isomerate, Cetyl Alcohol, Octyldodecanol, Ceteth-20, Dimethicone, Squalane, Arachidyl Propionate, Ascorbic Acid/Orange/Citrus Limon/Citrus Aurantifolia Polypeptides, Ascorbic Acid Polypeptide, Beta-Glucan, Ethylhexylglycerin, Ethyl Linolenate, Retinyl Palmitate, Tocopheryl Acetate, Ethyl Oleate, Lecithin, Linolenic Acid, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceratonia Siliqua (Carob) Gum, Steareth-2, Polysorbate 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

OIL-CONTROL

DAY LOTION SPF 15

90mL e 3.0 fl.oz.

Principal Display Panel - 90 mL Bottle Carton
OIL-CONTROL DAY SPF 15 
avobenzone and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57913-2857
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CETETH-20 (UNII: I835H2IHHX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SQUALANE (UNII: GW89575KF9)  
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYL LINOLENATE (UNII: T54Y8H042V)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYL OLEATE (UNII: Z2Z439864Y)  
LINOLENIC ACID (UNII: 0RBV727H71)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LOCUST BEAN GUM (UNII: V4716MY704)  
STEARETH-2 (UNII: V56DFE46J5)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57913-2857-81 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(57913-2857) , LABEL(57913-2857) , PACK(57913-2857)

Revised: 4/2013
Document Id: 5efdf937-f565-433c-a797-ff98d89e8cb9
Set id: 03301e1a-8d7c-4815-a95e-656b5ac7d049
Version: 1
Effective Time: 20130409
 
Erno Laszlo, Inc.