Keep the Peace Broad Spectrum SPF 20 Sunscreen Protective Color Corrector: Package Insert and Label Information

KEEP THE PEACE BROAD SPECTRUM SPF 20 SUNSCREEN PROTECTIVE COLOR CORRECTOR- titanium dioxide and zinc oxide lotion
Philosophy, Inc.

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.

Active Ingredients

Titanium Dioxide 4.8%

Zinc Oxide 3.0%

Purpose

Sunscreen

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun

Warnings

Do

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of reach of eyes. Rinse with water to remove.

Stop use and ask a doctor if rsh occurs.

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

cyclopentasiloxane, dimethicone crosspolymer, c12-15 alkyl benzoate, caprylic/capric triglyceride, dimethicone/vinyl dimethicone crosspolymer,

KTP Package Copy
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KEEP THE PEACE BROAD SPECTRUM SPF 20 SUNSCREEN PROTECTIVE COLOR CORRECTOR
titanium dioxide, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-1031
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 11.52 g in 60 mL
Zinc Oxide (ZINC OXIDE) Zinc Oxide 2.772 g in 60 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5
DIMETHICONE 100
C12-15 ALKYL BENZOATE
CAPRYLIC/CAPRIC ACID
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)
TOCOTRIENOLS
TOCOPHEROL
RICE BRAN
SQUALANE
LAVENDER OIL
SOYBEAN
DIMETHICONE
LINOLEIC ACID
OMEGA-3 FATTY ACIDS
CAPRYLYL GLYCOL
ALUMINUM OXIDE
PHENOXYETHANOL
TRIETHOXYCAPRYLYLSILANE
FERRIC OXIDE RED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50184-1031-2 1 TUBE in 1 BOX contains a TUBE (50184-1031-1)
1 NDC:50184-1031-1 60 mL in 1 TUBE This package is contained within the BOX (50184-1031-2)
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 Operations
Bio Tech Research Labs 948102256 manufacture (50184-1031)

Revised: 04/2013 Philosophy, Inc.

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