LAGOM CF CUSHION 10- titanium dioxide, octinoxate, octisalate cream 
SKINMED International Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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70738-003_V2

Titanium Dioxide 14.628%

Octinoxate 6.700%

Octisalate 4.000%

Sunscreen

Helps prevent sunburn

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

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

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

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LAGOM CF CUSHION 10 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70738-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.1462 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.067 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70738-003-021 in 1 CARTON11/30/2017
1NDC:70738-003-0114 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:70738-003-041 in 1 CARTON11/30/2017
2NDC:70738-003-0314 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/30/2017
Labeler - SKINMED International Co., Ltd. (689846920)
Registrant - SKINMED International Co., Ltd. (689846920)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(70738-003)

Revised: 10/2019
Document Id: 9589d5f0-f05a-74a7-e053-2995a90ac951
Set id: 245f6cb7-7416-4843-b8f2-fea371a76fcf
Version: 2
Effective Time: 20191022
 
SKINMED International Co., Ltd.