FIRMARINE MOISTURIZER 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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Firmarine™ Moisturizer SPF 30

Drug Facts

Active Ingredients

Avobenzone 3%, 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, Butylene Glycol, Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Glyceryl Stearate, Cetearyl Alcohol, Behenyl Alcohol, Palmitic Acid, Stearic Acid, Lecithin, Lauryl Alcohol, Cetyl Alcohol, Myristyl Alcohol, Coco-Glucoside, Ethylhexylglycerin, Dimethicone, PEG-100 Stearate, Spirulina Maxima Extract, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis Leaf Extract, Phospholipids, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Algae Extract, Pullulan, Sodium Hyaluronate, Trifluoroacetyl Tripeptide-2, Sea Water, Carbomer, Dextran, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Disodium EDTA, O-Cymen-5-Ol, Phenoxyethanol, Fragrance, Blue 1, Ext Violet 2.

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

Product label

image description

FIRMARINE MOISTURIZER SPF 30 
avobenzone, octinoxate, and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57913-2833
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
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 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)  
GLYCERIN (UNII: PDC6A3C0OX)  
JOJOBA OIL (UNII: 724GKU717M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DOCOSANOL (UNII: 9G1OE216XY)  
PALMITIC ACID (UNII: 2V16EO95H1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
LAURYL ALCOHOL (UNII: 178A96NLP2)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
COCO GLUCOSIDE (UNII: ICS790225B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
CUCUMBER (UNII: YY7C30VXJT)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57913-2833-01 in 1 CARTON04/10/2013
150 mL in 1 JAR; Type 0: Not a Combination Product
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(57913-2833) , LABEL(57913-2833) , PACK(57913-2833)

Revised: 8/2020
 
Erno Laszlo, Inc.