TONYMOLY MY SUNNY ALL IN ONE SUN SPF45- ethylhexyl methoxycinnamate cream

TONYMOLY My Sunny All In One Sun SPF45 by

Drug Labeling and Warnings

TONYMOLY My Sunny All In One Sun SPF45 by is a Otc medication manufactured, distributed, or labeled by Tonymoly Co., Ltd., Cosmax. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethylhexyl Methoxycinnamate 7.50%, Glycerin 6.47%, Octocrylene 2.00%, Titanium Dioxide 4.25%

Purpose

Sunscreen

Use

The all-in-one sun helps restore natural tone by providing moisture to the skin.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Keep out of reach of children

Keep out of reach of children.

Directions

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

Inactive Ingredients

Water, Ethylhexyl Palmitate, Cyclopentasiloxane, 4-Methylbenzylidene Camphor, Butyl Methoxydibenzoylmethane, Cyclohexasiloxane, Butylene Glycol, Neopentyl Glycol Diheptanoate, Ethylhexyl Salicylate, Polymethyl Methacrylate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Triceteareth-4 Phosphate, Glycol Stearate, Silica, Sorbitan Sesquioleate, Potassium Cetyl Phosphate, PEG-2 Stearate, Tromethamine, Phenoxyethanol, Glyceryl Caprylate, Fragrance(Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Caprylyl Glycol, Dimethicone, Iron Oxides (CI 77492), Disodium EDTA, Iron Oxides (CI 77491), Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Water, Anthemis Nobilis Flower Water, Polydecene, Dipropylene Glycol, Prunus Mume Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Sodium Palmitoyl Proline, Codium Tomentosum Extract, Enteromorpha Compressa Extract, Macrocystis Pyrifera (Kelp) Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Laminaria Japonica Extract, Nymphaea Alba Flower Extract, Squalane, Chamaecyparis Obtusa Leaf Extract, Viscum Album (Mistletoe) Fruit Extract, Coco-Glucoside, Vanilla Tahitensis Fruit Extract, Benzyl Alcohol, Sansevieria Trifasciata Leaf Extract, Portulaca Oleracea Extract, Sorbic Acid, Ethylhexylglycerin, Potassium Sorbate, Dehydroacetic Acid, Sodium Benzoate

Principal Display Panel

INGREDIENTS AND APPEARANCE

TONYMOLY MY SUNNY ALL IN ONE SUN SPF45 
other skin care preparations cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	17977.5 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	8145.73 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2100 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PRUNUS MUME FRUIT (UNII: 639190I8CU)
GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)
SQUALANE (UNII: GW89575KF9)
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)
ENZACAMENE (UNII: 8I3XWY40L9)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ORANGE (UNII: 5EVU04N5QU)
OCTISALATE (UNII: 4X49Y0596W)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
ULVA COMPRESSA (UNII: SXZ209FM33)
COCO GLUCOSIDE (UNII: ICS790225B)
VANILLA (UNII: Q74T35078H)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
ECKLONIA CAVA (UNII: UXX2N5V39P)
LAMINARIA JAPONICA (UNII: WE98HW412B)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
VISCUM ALBUM FRUIT (UNII: P83EQ521R3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TROMETHAMINE (UNII: 023C2WHX2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
SANSEVIERIA TRIFASCIATA LEAF (UNII: S3B72UOI9O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ACETYL TETRAPEPTIDE-15 (UNII: 6K389LE0MV)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PEG-2 STEARATE (UNII: 94YQ11Y95F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCOL STEARATE (UNII: 0324G66D0E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
CODIUM TOMENTOSUM (UNII: B8B45BRU87)
SORBIC ACID (UNII: X045WJ989B)
VISCUM ALBUM WHOLE (UNII: E6839Q6DO1)
AVOBENZONE (UNII: G63QQF2NOX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-125-01	1 in 1 CARTON	01/19/2016
1		100 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 final	part352	01/14/2016

Labeler - Tonymoly Co., Ltd. (688216798)

Registrant - Tonymoly Co., Ltd. (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax		689049693	manufacture(59078-125)