NDC | 71014-013-01 |
Set ID | 799e358f-f796-4c1c-e053-2991aa0a9fe4 |
Category | HUMAN OTC DRUG LABEL |
Packager | Eai-jr 286, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
• Apply liberally and generously 15 minutes before sun exposure and at least
every 2 hours.• Reapply:
• after 80 minutes of swimming or sweating • immediately after towel drying
• at least every 2 hours.• 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 your time in the sun, especially from 10
a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses• Children under 6 months of age: ask a doctor.
-
INACTIVE INGREDIENT
Inactive ingredients:
Water, Isododecane, Dimethicone, Glycerin, Tapioca starch, Pentylene Glycol, Cetearyl Alcohol, Polyurethane-34, Polysilicone-11, Isododecane, Coco-Caprylate/-Caprate, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Hydrolyzed Hibiscus Esculentes Extract, Butylene Glycol, SOdium Polyacrylate, Dextrin, Citrus Sinensis (Blood Orange) Fruit Extract, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Ethylhexyl Stearate, Xanthan Gum, Ammonium Acryloyldeimethyltaurate/VP Copolymer, Fragrance, Chlorphenesin, Aloe Barbadensis Leaf Juice, Sodium Citrate, Tocopheryl Acetate, Trideceth-6, Leuconostoc/Radish root ferment Filtrate, Disodium EDTA, Decyl Glucoside, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Aminomethyl Propanol
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAILY DRIVER SUNSCREEN BROAD SPECTRUM SPF 30
homosalate, octisalate, avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71014-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 g in 100 mL Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) CITRUS SINENSIS WHOLE (UNII: 37673443KL) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM CITRATE (UNII: 1Q73Q2JULR) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) STARCH, TAPIOCA (UNII: 24SC3U704I) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) ICODEXTRIN (UNII: 2NX48Z0A9G) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) PEG-100 STEARATE (UNII: YD01N1999R) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) TRIDECETH-6 (UNII: 3T5PCR2H0C) ISODODECANE (UNII: A8289P68Y2) PENTYLENE GLYCOL (UNII: 50C1307PZG) CAPRYLYL GLYCOL (UNII: 00YIU5438U) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71014-013-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/02/2018 Labeler - Eai-jr 286, Inc (827896718) Establishment Name Address ID/FEI Business Operations Northwest Cosmetic Laboratories LLC 929572014 manufacture(71014-013)