Keep The Peace Protect and Correct: Package Insert and Label Information

KEEP THE PEACE PROTECT AND CORRECT — titanium dioxide and zinc oxide cream
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.

TITANIUM DIOXIDE……4.8%

ZINC OXIDE……….3.0%

CYCLOPENTASILOXANE, DIMETHICONE CROSSPOLYMER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BEHENOXY DIMETHICONE, PHYTOSTEROLS, TOCOTRIENOLS, TOCOPHEROL, ORYZA SATIVA (RICE) BRAN WAX, SQUALENE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, GLYCINE SOJA (SOYBEAN) STEROLS, DIMETHICONE, CETEARYL METHICONE, LINOLEIC ACID, PHOSPHOLIPIDS, POLYHYDROXYSTEARIC ACID, BISABOLOL, CAPYLYL GLYCOL, SIMETHICONE, ALUMINA, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77491, 77492, 77499).

Sunscreen

Uses: helps prevent suburn

higher SPF gives more sunburn protection

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT.

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE

STOP USE AND ASK DOCTOR IF A RASH OR IRRITATION DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

QUESTIONS? CALL — 1-800-568-3515

MM1
(click image for full-size original)

KEEP THE PEACE PROTECT AND CORRECT
titanium dioxide and zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-6600
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.88 mL in 60 mL
ZINC OXIDE (ZINC CATION) ZINC OXIDE 1.8 mL in 60 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5
DIMETHICONE
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
ALPHA-TOCOPHEROL
RICE BRAN
SQUALENE
ENGLISH LAVENDER OIL
SOYBEAN
DIMETHICONE
LINOLEIC ACID
EGG PHOSPHOLIPIDS
LEVOMENOL
CAPRYLYL GLYCOL
ALUMINUM OXIDE
PHENOXYETHANOL
OCTYLTRIETHOXYSILANE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50184-6600-1 60 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/24/2011
Labeler — Philosophy, Inc. (948102256)
Establishment
Name Address ID/FEI Operations
Philosophy Inc for BioTech Research Labs 948102256 manufacture

Revised: 01/2011 Philosophy, Inc.

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