Label: LAGOM CF CUSHION 10- titanium dioxide, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70738-003-01, 70738-003-02, 70738-003-03, 70738-003-04 - Packager: SKINMED International Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 22, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
LAGOM CF CUSHION 10
titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70738-003 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:70738-003-02 1 in 1 CARTON 11/30/2017 1 NDC:70738-003-01 14 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:70738-003-04 1 in 1 CARTON 11/30/2017 2 NDC:70738-003-03 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(70738-003)
