NDC | 75936-142-01, 75936-142-02, 75936-142-03, 75936-142-04, 75936-142-05, 75936-142-06 |
Set ID | d8ac12f2-485c-4b28-847b-e12d034ee075 |
Category | HUMAN OTC DRUG LABEL |
Packager | TAYLOR JAMES, LTD. |
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 generously and evenly 15 minutes before sun exposure
- reapply:
after 40 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 time in the sun, especially from 10 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: ask a doctor
-
INACTIVE INGREDIENT
Inactive Ingredients
Isododecane, Dimethicone Crosspolymer, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Isohexadecane, Dicrapylyl Carbonate, Meadowfoam Estolide, Polyester-8,Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Lithothamnion Calcareum Extract,Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Diethylhexyl Syringylidenemalonate, Mannitol, Olibanum, Lecithin, Microcrystalline Cellulose, Diatomaceous Earth, Zinc Sulfate, Silica, Tocopherol
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40
avobenzone, homosalate, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-142 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 8 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) ISOHEXADECANE (UNII: 918X1OUF1E) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) SHEA BUTTER (UNII: K49155WL9Y) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) MANNITOL (UNII: 3OWL53L36A) FRANKINCENSE (UNII: R9XLF1R1WM) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85) ZINC SULFATE (UNII: 89DS0H96TB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-142-02 1 in 1 CARTON 10/12/2017 1 NDC:75936-142-01 50 mL in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:75936-142-06 15 mL in 1 TUBE; Type 0: Not a Combination Product 10/12/2017 3 NDC:75936-142-03 10 mL in 1 PACKAGE; Type 0: Not a Combination Product 10/12/2017 4 NDC:75936-142-04 5 mL in 1 PACKAGE; Type 0: Not a Combination Product 10/12/2017 5 NDC:75936-142-05 1.5 mL in 1 PACKAGE; Type 0: Not a Combination Product 10/12/2017 6 NDC:75936-142-07 20 mL in 1 CARTON; Type 0: Not a Combination Product 01/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/10/2017 Labeler - TAYLOR JAMES, LTD. (033381850) Establishment Name Address ID/FEI Business Operations Cosway Company Inc. 052400223 manufacture(75936-142)