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

MD Restoring daily Defense Moisturizer SPF 50 by

Drug Labeling and Warnings

MD Restoring daily Defense Moisturizer SPF 50 by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Titanium Dioxide 6.5%

Zinc Oxide 8.7%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes Rinse with water to remove

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

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

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

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

INGREDIENTS AND APPEARANCE

MD RESTORING DAILY DEFENSE MOISTURIZER SPF 50 
zinc oxide and titanium dioxide cream

Product 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)