RESTORE PLUS DEFENSE ACNE SAFE FACIAL MINERAL SUNSCREEN LIGHTLY TINTED- zinc oxide cream

Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted by

Drug Labeling and Warnings

Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted by is a Otc medication manufactured, distributed, or labeled by NY BEAUTY PALACE LLC, Fragrance Manufacturing INC, Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

INDICATIONS & USAGE

WARNINGS

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

OTHER SAFETY INFORMATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RESTORE PLUS DEFENSE ACNE SAFE FACIAL MINERAL SUNSCREEN LIGHTLY TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85404-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CI 77499 (UNII: XM0M87F357)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CERAMIDE 3 (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85404-208-15	1.5 g in 1 PACKET; Type 0: Not a Combination Product	07/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/07/2021

Labeler - NY BEAUTY PALACE LLC (013163173)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85404-208)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85404-208)