LAGOM CF CUSHION 20- titanium dioxide, octinoxate, octisalate cream

Lagom CF Cushion 20 by

Drug Labeling and Warnings

Lagom CF Cushion 20 by is a Otc medication manufactured, distributed, or labeled by SKINMED International Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 14.628%

Octinoxate 6.700%

Octisalate 4.000%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

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 using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclohexasiloxane, Diisostearyl Malate, Butylene Glycol, Glycerin, Butylene Glycol Dicaprylate/Dicaprate, C12-15 Alkyl Benzoate, Niacinamide, PEG-10 Dimethicone, Pentylene Glycol, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Phenyl Trimethicone, Polypropylsilsesquioxane, Iron Oxides (CI 77492), Disteardimonium Hectorite, Magnesium Sulfate, Phenoxyethanol, Synthetic Fluorphlogopite, Sorbitan Isostearate, Stearic Acid, Alumina, Aluminum Hydroxide, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Dimethicone/Vinyl Dimethicone, Crosspolymer, Urea, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Citrus Limon (Lemon) Peel Oil, Disodium EDTA, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Biosaccharide Gum-4, Phytosphingosine, Sapphire Powder, Cymbopogon Schoenanthus Oil, Hydrolyzed Vegetable Protein, Maltodextrin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LAGOM CF CUSHION 20 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70738-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.1462 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.067 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
UREA (UNII: 8W8T17847W)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
LEMON OIL (UNII: I9GRO824LL)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MANDARIN OIL (UNII: NJO720F72R)
ORANGE OIL (UNII: AKN3KSD11B)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70738-004-02	1 in 1 CARTON	11/30/2017
1	NDC: 70738-004-01	14 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 70738-004-04	1 in 1 CARTON	11/30/2017
2	NDC: 70738-004-03	14 g in 1 CONTAINER; 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	11/30/2017

Labeler - SKINMED International Co., Ltd. (689846920)

Registrant - SKINMED International Co., Ltd. (689846920)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(70738-004)