MALIN AND GOETZ SPF 30 FACE MOISTURIZER- avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream

Malin and Goetz by

Drug Labeling and Warnings

Malin and Goetz by is a Otc medication manufactured, distributed, or labeled by Malin + Goetz, Milbar Laboratories,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
avobenzone 3%	sunscreen
homosalate 10%	sunscreen
octinoxate 7.5%	sunscreen
octisalate 5%	sunscreen
oxybenzone 5%	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 or irritation develops and lasts

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

Directions

• Apply generously and evenly 15 minutes before sun exposure to clean face
• Use a water resistant sunscreen if swimming or sweating
• Reapply 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 of age: Ask a doctor. Smooth onto face and neck until thoroughly absorbed

Inactive Ingredients

Water (aqua), c12-15 alkyl ethylhexanoate, dimethicone, glycerin, vp/eicosene copolymer, phenoxyethanol, peg-20 methyl glucose sesquistearate, methyl glucose sesquistearate, cetyl alcohol, potassium cetyl phosphate, acrylates/c10-30 alkyl acrylate cross- polymer, peg-40 stearate, chlorph- enesin, polysorbate 80, cholesterol, ethylhexylglycerin, sodium benzoate, sodium hydroxide, disodium edta, methylisothiazolinone, panthenol, tetrahexyldecyl ascorbate, aloe barbadensis leaf juice powder, allantoin, tocopherol, camellia oleifera leaf extract, epilobium angustifolium flower/leaf/stem extract

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Visit www.malinandgoetz.com or call +1-212-244-7771, M-F, 9am-6pm EST

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DISTRIBUTED BY:
MALIN+GOETZ INC.,
210 WEST 29TH ST.,
NEW YORK, NEW YORK 10001

PRINCIPAL DISPLAY PANEL - 48 mL Tube Carton

(MALIN+GOETZ)
spf 30 face moisturizer.

BROAD SPECTRUM SPF 30. ALL SKIN TYPES.
APOTHECARY AND LAB—FM-118-48.

BROAD SPECTRUM SPF 30 HELPS PROTECT AGAINST
SUN DAMAGE WHILE GREEN TEA ANTIOXIDANTS PRO-
VIDE PROTECTION AGAINST ENVIRONMENTAL TOXINS
AND FREE RADICALS. GENTLY MOISTURIZES AND BAL-
ANCES ALL SKIN TYPES. NATURAL FRAGRANCE AND
COLOR. DIRECTIONS: APPLY GENEROUSLY AND EVENLY TO
CLEAN FACE 15 MINUTES BEFORE SUN EXPOSURE. USE A
WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6
MONTHS OF AGE: ASK A DOCTOR. SMOOTH ONTO FACE AND
NECK UNTIL THOROUGHLY ABSORBED. WARNINGS: FOR EXT-
ERNAL 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 OR IRRITATION DEVELOPS AND LASTS. KEEP OUT OF
REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR
CONTACT A POISON CONTROL CENTER RIGHT AWAY. FORM-
ULATED AND DISTRIBUTED BY: MALIN+GOETZ INC., 210 WEST
29TH ST., NEW YORK, NEW YORK 10001, TEL +1 212 244 7771.
WWW.MALINANDGOETZ.COM. MALIN+GOETZ DOES NOT TEST
ON ANIMALS. MADE IN USA.

1.7fl.oz.℮48ml

INGREDIENTS AND APPEARANCE

MALIN AND GOETZ   SPF 30 FACE MOISTURIZER
avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53634-254
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
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S)	homosalate	100 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
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y)	oxybenzone	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
c12-15 alkyl ethylhexanoate (UNII: GQJ580CH83)
dimethicone (UNII: 92RU3N3Y1O)
glycerin (UNII: PDC6A3C0OX)
phenoxyethanol (UNII: HIE492ZZ3T)
peg-20 methyl glucose sesquistearate (UNII: 0345752X7U)
cetyl alcohol (UNII: 936JST6JCN)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
peg-40 stearate (UNII: ECU18C66Q7)
chlorphenesin (UNII: I670DAL4SZ)
polysorbate 80 (UNII: 6OZP39ZG8H)
cholesterol (UNII: 97C5T2UQ7J)
ethylhexylglycerin (UNII: 147D247K3P)
sodium benzoate (UNII: OJ245FE5EU)
sodium hydroxide (UNII: 55X04QC32I)
edetate disodium (UNII: 7FLD91C86K)
methylisothiazolinone (UNII: 229D0E1QFA)
panthenol (UNII: WV9CM0O67Z)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
aloe vera leaf (UNII: ZY81Z83H0X)
allantoin (UNII: 344S277G0Z)
tocopherol (UNII: R0ZB2556P8)
camellia oleifera leaf (UNII: 5077EL0C60)
epilobium angustifolium flowering top (UNII: 08H094218D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53634-254-50	1 in 1 CARTON
1		48 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2014

Labeler - Malin + Goetz (138615930)

Registrant - Milbar Laboratories,Inc. (195556790)

Establishment
Name	Address	ID/FEI	Business Operations
Milbar Laboratories,Inc.		195556790	MANUFACTURE(53634-254)