FIRMARINE MOISTURIZER SPF 30- avobenzone, octinoxate, and octisalate lotion

Firmarine Moisturizer SPF 30 by

Drug Labeling and Warnings

Firmarine Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Erno Laszlo, Inc., Mana Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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.

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DISTRIBUTED IN U.S.A. BY ERNO LASZLO NEW YORK, NY 10001

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

ERNO
LASZLO

NEW YORK

FIRMARINE™

MOISTURIZER SPF 30

50mL e 1.7 fl.oz.

INGREDIENTS AND APPEARANCE

FIRMARINE MOISTURIZER SPF 30 
avobenzone, octinoxate, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57913-2833
Route of Administration	TOPICAL

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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57913-2833-0	1 in 1 CARTON
1		50 mL in 1 JAR

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(57913-2833) , LABEL(57913-2833) , PACK(57913-2833)