NDC | 70528-018-11, 70528-018-51 |
Set ID | 2ab19062-25ab-46a1-9f36-d02dd1c66f38 |
Category | HUMAN OTC DRUG LABEL |
Packager | ZRII, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
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 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 10 a.m.– 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- OTHER INFORMATION
-
INACTIVE INGREDIENTS
Aqua, Carthamus Tinctorius (Safflower) Oleosomes, Glyceryl Stearate, Cetearyl Alcohol, Isodecyl Neopentanoate, Ceteareth-20, Cetyl Alcohol, Niacinamide, Caprylic/Capric Triglycerides (and) Sea Whip Extract, Diisopropyl Sebacate, Lauryl Lactate, Ascorbyl Glucoside, Tocopheryl Acetate, 7-Dehydrocholesterol, Sodium Polyacrylate, Sodium Citrate, Carbomer, Hexylene Glycol, Disodium Edta, Sodium Hydroxide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Citric Acid
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZRII NEW DAY BROAD SPECTRUM SPF-30
avobenzone, homosalate, octinoxate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70528-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SAFFLOWER OIL (UNII: 65UEH262IS) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) CETEARETH-22 (UNII: 28VZG1E234) CETYL ALCOHOL (UNII: 936JST6JCN) NIACINAMIDE (UNII: 25X51I8RD4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) LAURYL LACTATE (UNII: G5SU0BFK7O) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) SODIUM CITRATE (UNII: 1Q73Q2JULR) CARBOMER 940 (UNII: 4Q93RCW27E) HEXYLENE GLYCOL (UNII: KEH0A3F75J) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70528-018-51 1 in 1 BOX 07/05/2016 1 NDC:70528-018-11 50 mL 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 part352 07/05/2016 Labeler - ZRII, LLC (807457531) Establishment Name Address ID/FEI Business Operations Westwood Laboratories Inc. 069926483 manufacture(70528-018)