Malin And Goetz Spf 15 Face Moisturizer (Octinoxate, Octisalate, Oxybenzone) Cream [Malin & Goetz Inc] -

MALIN AND GOETZ SPF 15 FACE MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [MALIN & GOETZ INC]
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NDC	53634-152-01
Set ID	35e5cb7a-68a1-47f4-aa53-51b3a7503658
Category	HUMAN OTC DRUG LABEL
Packager	Malin & Goetz Inc
Generic Name
Product Class
Product Number
Application Number	PART352

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ACTIVE INGREDIENT

Active ingredients purpose

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Oxybenzone 2% Sunscreen

Uses

For skin highly sensitive for sunburn

helps prevent sunburn

higher SPF gives more sunburn protection

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

Stop use and ask a doctor if skin rash occurs

Warnings

For external use only

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothin and using a sunscreen

Directions
Apply liberally before sun exposure. Apply and reapply as directed to avoid lowering protection.
Reapply at least every 2 hours. Children under 6 months: Ask a doctor

Water (Aqua), Octyl Dodecyl Neopentanoate, Isocetyl stearate, glycerin, cetyl alcohol, glyceryl stearate, PEG-100 Stearate, Persea Gratissima (Avocado) Oil, Phytosterols, Olea Europaea (olive) Fruit oil, Butyrospermum Parkii (Shea butter), Ormenis Multicaulis, Tocopheryl Acetate, Butylene Glycol, Camellia Oleifera Leaf Extract, Magnesium Ascorbyl Phosphate, Cyano-cobalamin, Cholecalciferol, Retinyl Palmitate, C13-C16 Isoparaffin, C12-C14 Isoparaffin, C13-C15 Alkane, Titanium Dioxide, Polysorbate 80, Carbomer, Triethanolamine, phenoxyethanol, Sodium Dehydroacetate.
PRINCIPAL DISPLAY PANEL

(Malin + Goetz)

spf 15 face moisturizer.

UVA +UVB Broad Spectrum. All skin types. Fatty Acid Absorption technology-FM-110-04

4 fl. oz. e 118ml.

INGREDIENTS AND APPEARANCE

MALIN AND GOETZ SPF 15 FACE MOISTURIZER
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53634-152
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
AVOCADO OIL (UNII: 6VNO72PFC1)
OLIVE OIL (UNII: 6UYK2W1W1E)
SHEA BUTTER (UNII: K49155WL9Y)
CLADANTHUS MIXTUS FLOWER VOLATILE OIL (UNII: RAY2FRM711)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
C13-15 ALKANE (UNII: 114P5I43UJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOMER 934 (UNII: Z135WT9208)
trolamine (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53634-152-01	118 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/02/2012

Labeler - Malin & Goetz Inc (138615930)

Registrant - Malin & Goetz Inc (138615930)

Name	Address	ID/FEI	Business Operations
Establishment
D'ARCY ACQUISITION, LLC		101381952	manufacture(53634-152)

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Medic

MALIN AND GOETZ SPF 15 FACE MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [MALIN & GOETZ INC]

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