NDC | 50184-1031-1, 50184-1031-2 |
Set ID | f2c9c896-1749-43ee-bf12-9747aff6746a |
Category | HUMAN OTC DRUG LABEL |
Packager | Philosophy, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Keep Out of Reach of Children.
- Uses
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least ever 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 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-sleeve shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KEEP THE PEACE BROAD SPECTRUM SPF 20 SUNSCREEN PROTECTIVE COLOR CORRECTOR
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-1031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 11.52 g in 60 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide 2.772 g in 60 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE 100 (UNII: RO266O364U) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) CAPRYLIC/CAPRIC ACID (UNII: DI775RT244) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) TOCOTRIENOLS (UNII: KP2MW85SSQ) TOCOPHEROL (UNII: R0ZB2556P8) RICE BRAN (UNII: R60QEP13IC) SQUALANE (UNII: GW89575KF9) LAVENDER OIL (UNII: ZBP1YXW0H8) SOYBEAN (UNII: L7HT8F1ZOD) DIMETHICONE (UNII: 92RU3N3Y1O) LINOLEIC ACID (UNII: 9KJL21T0QJ) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM OXIDE (UNII: LMI26O6933) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50184-1031-2 1 in 1 BOX 1 NDC:50184-1031-1 60 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2013 Labeler - Philosophy, Inc. (948102256) Establishment Name Address ID/FEI Business Operations Bio Tech Research Labs 948102256 manufacture(50184-1031)