Label: KEEP THE PEACE BROAD SPECTRUM SPF 20 SUNSCREEN PROTECTIVE COLOR CORRECTOR- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 50184-1031-1, 50184-1031-2 - Packager: Philosophy, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 4, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep Out of Reach of Children.
- Uses
- Warnings
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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
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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)