NDC | 46783-222-30 |
Set ID | 62c822d9-c8ed-4b95-8d88-806295f5a936 |
Category | HUMAN OTC DRUG LABEL |
Packager | Merz North America, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Active Ingredients
- Purpose
-
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
-
Directions
- apply generously 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
-
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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am - 2pm
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: ask a doctor
-
Inactive Ingredients
Cyclopentasiloxane, Ascorbic Acid, Ethylhexyl Hydroxystearate, Polysilicone-11, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Polyester-7, Tocopherol, Creatine, Epigallocatechin Gallate, Triethoxycaprylylsilane, Neopentyl Glycol Diheptanoate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Propylene Carbonate, Dimethylmethoxy Chromanol, BHT
- Other Information
- Questions?
- PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
-
INGREDIENTS AND APPEARANCE
REACTIVE PLUS ANTI-OXIDANT SERUM PLUS BROAD-SPECTRUM SPF 45
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46783-222 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 51 mg in 1 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) POLYSILICONE-15 (UNII: F8DRP5BB29) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) POLYESTER-7 (UNII: 0841698D2F) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CREATINE (UNII: MU72812GK0) EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPYLENE CARBONATE (UNII: 8D08K3S51E) DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46783-222-30 1 in 1 CARTON 06/01/2018 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:46783-222-04 4 mL in 1 TUBE; Type 0: Not a Combination Product 06/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2018 Labeler - Merz North America, Inc (028147846)