OTC Medication Information: Lagom CF Cushion 20

LAGOM CF CUSHION 20- titanium dioxide, octinoxate and 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.

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 20
titanium dioxide, octinoxate, octisalate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70738-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.1462 g in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.067 g in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 0.04 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
DIPHENYLSILOXY PHENYL TRIMETHICONE
CYCLOMETHICONE 6
DIISOSTEARYL MALATE
BUTYLENE GLYCOL
GLYCERIN
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
ALKYL (C12-15) BENZOATE
NIACINAMIDE
PEG-10 DIMETHICONE (600 CST)
PENTYLENE GLYCOL
PHENYL TRIMETHICONE
FERRIC OXIDE YELLOW
DISTEARDIMONIUM HECTORITE
MAGNESIUM SULFATE, UNSPECIFIED FORM
PHENOXYETHANOL
SORBITAN ISOSTEARATE
STEARIC ACID
ALUMINUM OXIDE
ALUMINUM HYDROXIDE
TRIETHOXYCAPRYLYLSILANE
FERROSOFERRIC OXIDE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)
UREA
BERGAMOT OIL
ETHYLHEXYLGLYCERIN
ADENOSINE
LEMON OIL
EDETATE DISODIUM ANHYDROUS
MANDARIN OIL
ORANGE OIL
BIOSACCHARIDE GUM-4
PHYTOSPHINGOSINE
CYMBOPOGON SCHOENANTHUS OIL
MALTODEXTRIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70738-004-02 1 CONTAINER in 1 CARTON contains a CONTAINER (70738-004-01)
1 NDC:70738-004-01 14 g in 1 CONTAINER This package is contained within the CARTON (70738-004-02)
2 NDC:70738-004-04 1 CONTAINER in 1 CARTON contains a CONTAINER (70738-004-03)
2 NDC:70738-004-03 14 g in 1 CONTAINER This package is contained within the CARTON (70738-004-04)
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 Operations
Cosmax, Inc. 689049693 manufacture (70738-004)

Revised: 10/2019 SKINMED International Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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