Label: MD RESTORING DAILY DEFENSE MOISTURIZER SPF 50- zinc oxide and titanium dioxide cream
- NDC Code(s): 62742-4220-1, 62742-4220-2, 62742-4220-3
- Packager: Allure Labs Inc
- 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 21, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions • Apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures inducing: • limit time in the sun, especially from 10 am.-2 p.m. • wear long-sleeved shits, pants, hats and sunglasses
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredient:
CYCLOPENTASILOXANE, AQUA/WATER/EAU, C12-15 ALKYL BENZOATE, DIMETHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/PEG-10/15 CROSSPOLYMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM CHLORIDE, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, PEG/PPG-18/18 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, PHENOXYETHANOL, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LIMONENE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, CYCLOHEXASILOXANE, SORBITAN OLIVATE, ETHYLHEXYL PALMITATE, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, PEG-8, TOCOPHERYL ACETATE, TOCOPHEROL, ISOMALT, BENZOIC ACID, DIPROPYLENE GLYCOL, PROPYLENE GLYCOL, BUTYLENE GLYCOL, VANILLA PLANIFOLIA FRUIT EXTRACT, SODIUM CITRATE, ASCORBYL PALMITATE, SILICA DIMETHYL SILYLATE, PENTYLENE GLYCOL, ASCORBIC ACID, CITRIC ACID, POLYGONUM AVICULARE EXTRACT, BAROSMA BETULINA LEAF OIL, CAESALPINIA SPINOSA FRUIT POD EXTRACT, CARBOMER, SODIUM LACTATE, SODIUM BENZOATE, POLYSORBATE 20, SODIUM HYALURONATE, LECITHIN, POTASSIUM SORBATE, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SODIUM FERROCYANIDE, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MD RESTORING DAILY DEFENSE MOISTURIZER SPF 50
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.7 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.5 g in 100 g Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) SUNFLOWER OIL (UNII: 3W1JG795YI) HEXYLENE GLYCOL (UNII: KEH0A3F75J) MANDARIN OIL (UNII: NJO720F72R) AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM CHLORIDE (UNII: 451W47IQ8X) HEXYL LAURATE (UNII: 4CG9F9W01Q) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) SORBITAN OLIVATE (UNII: MDL271E3GR) ETHYLHEXYL PALMITATE (UNII: 2865993309) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TOCOPHEROL (UNII: R0ZB2556P8) BENZOIC ACID (UNII: 8SKN0B0MIM) DIPROPYLENE GLYCOL (UNII: E107L85C40) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) VANILLA (UNII: Q74T35078H) SODIUM CITRATE (UNII: 1Q73Q2JULR) ASCORBYL PALMITATE (UNII: QN83US2B0N) PENTYLENE GLYCOL (UNII: 50C1307PZG) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) SODIUM LACTATE (UNII: TU7HW0W0QT) POLYSORBATE 20 (UNII: 7T1F30V5YH) VITIS VINIFERA ANTHOCYANINS (UNII: F02KPB2508) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SODIUM FERROCYANIDE (UNII: 5HT6X21AID) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ORANGE OIL (UNII: AKN3KSD11B) LIMONENE, (+)- (UNII: GFD7C86Q1W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PHENOXYETHANOL (UNII: HIE492ZZ3T) ISOMALT (UNII: S870P55O2W) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) ASCORBIC ACID (UNII: PQ6CK8PD0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) SODIUM BENZOATE (UNII: OJ245FE5EU) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CETEARYL OLIVATE (UNII: 58B69Q84JO) CYCLOMETHICONE 6 (UNII: XHK3U310BA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4220-1 7 g in 1 TUBE; Type 0: Not a Combination Product 10/21/2022 2 NDC:62742-4220-3 1 in 1 CARTON 10/21/2022 2 NDC:62742-4220-2 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/21/2022 Labeler - Allure Labs Inc (926831603) Registrant - Allure Labs Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs Inc 926831603 manufacture(62742-4220)
