Label: LAUNDRYOU MOISTURE SUN CUSHION CLEAR- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 83024-001-01, 83024-001-02 - Packager: bvmt Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 5, 2022
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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, Isononyl Isononanoate, Butyloctyl Salicylate, Propanediol, Caprylyl Methicone, Propylheptyl Caprylate, Trimethylsiloxysilicate, Acrylates Copolymer, Alcohol, Lauryl Polyglyceryl-3, Polydimethylsiloxyethyl Dimethicone, C12-15 Alkyl Benzoate, C18-21 Alkane, Methyl Trimethicone, Polyglyceryl-2 Dipolyhydroxystearate, Polyhydroxystearic Acid, Disteardimonium Hectorite, Isododecane, Magnesium Sulfate, 1,2-Hexanediol, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Hydroxyacetophenone, Trisodium Ethylenediamine Disuccinate, Polyglycerin-6, Origanum Vulgare Leaf Extract, Tocopherol, Chamaecyparis Obtusa Leaf Extract, Glycerin, Sea Water, Potassium Benzoate, Ascorbyl Palmitate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LAUNDRYOU MOISTURE SUN CUSHION CLEAR
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83024-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10.03 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 4.9 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) ALCOHOL (UNII: 3K9958V90M) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) C18-C21 ALKANE (UNII: 33822S0M40) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ISODODECANE (UNII: A8289P68Y2) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) POLYGLYCERIN-6 (UNII: M51422LRAM) OREGANO (UNII: 0E5AT8T16U) TOCOPHEROL (UNII: R0ZB2556P8) CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) POTASSIUM BENZOATE (UNII: 763YQN2K7K) ASCORBYL PALMITATE (UNII: QN83US2B0N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83024-001-02 1 in 1 CARTON 10/05/2022 1 NDC:83024-001-01 25 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 final part352 10/05/2022 Labeler - bvmt Co.,Ltd. (695523184) Registrant - bvmt Co.,Ltd. (695523184) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(83024-001)
