MD RESTORING DAILY DEFENSE MOISTURIZER SPF 50- zinc oxide and titanium dioxide cream 
Allure Labs Inc

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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Drug Facts

Active ingredients

Titanium Dioxide 6.5%

Zinc Oxide 8.7%

Purpose

Sunscreen

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions). decreases the risk of skin cancer and early skin aging caused by the Sun

Warnings

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 use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed. get medical help or contact a Poison Control Center right away

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 information • protect the product in this container from excessive heat and direct sun

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

MDRestoring

MD RESTORING DAILY DEFENSE MOISTURIZER SPF 50 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8.7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4220-17 g in 1 TUBE; Type 0: Not a Combination Product10/21/2022
2NDC:62742-4220-31 in 1 CARTON10/21/2022
2NDC:62742-4220-257 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/21/2022
Labeler - Allure Labs Inc (926831603)
Registrant - Allure Labs Inc (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs Inc926831603manufacture(62742-4220)

Revised: 10/2022
Document Id: eb8e7109-b5ec-5cc1-e053-2995a90a486f
Set id: eb8e7109-b5eb-5cc1-e053-2995a90a486f
Version: 1
Effective Time: 20221021
 
Allure Labs Inc