Label: CALM IT DOWN KIT- titanium dioxide, zinc oxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 49520-502-64 - Packager: mybody
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 30, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DO NOT USE
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DOSAGE & ADMINISTRATION
DIRECTIONS
USE AM. APPLY AS NEEDED TO FACE AND NECK AREA. CAN ALSO BE APPLIED TO THE EARS, HANDS AND DECOLETAGE. APPLY EVENLY 15-30 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED. REAPPLY AS NEEDED OR AFTER SWIMMING OR PERSPIRING. FOR BEST RESULTS
- CLEANSE SKIN THOROUGHLY BEFORE APPLYING.
- APPLY LIBERALLY TO FACE AND NECK BEFORE SUN EXPOSURE.
- USE ALONE OR UNDER MAKE-UP.
- CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, CYCLOMETHICONE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, SORBITAN ISOSTEARATE, TRIBEHENIN, CALCIUM BEHENATE, MELANIN, DIMETHICONOL, ALUMINA, PEG-10 DIMETHICONE, METHICONE, IRON OXIDES, CHOLECALCIFEROL, LYCOPENE, GLYCERIN, SUCROSE PALMITATE, LECITHIN.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CALM IT DOWN KIT
titanium dioxide, zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49520-502 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49520-502-64 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 Part 3 1 Part 4 1 Part 1 of 4 PROTECT AND SERVE TINTED SUN SHIELD SPF 30
titanium dioxide and zinc oxide lotionProduct Information Item Code (Source) NDC:49520-301 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 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE (UNII: NMQ347994Z) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) TRIBEHENIN (UNII: 8OC9U7TQZ0) CALCIUM BEHENATE (UNII: J5VFA9V6YG) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW) ALUMINUM OXIDE (UNII: LMI26O6933) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) METHICONE (20 CST) (UNII: 6777U11MKT) FERRIC OXIDE RED (UNII: 1K09F3G675) CHOLECALCIFEROL (UNII: 1C6V77QF41) LYCOPENE (UNII: SB0N2N0WV6) GLYCERIN (UNII: PDC6A3C0OX) SUCROSE PALMITATE (UNII: 3OSQ643ZK5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/23/2012 Part 2 of 4 CLEAN ROUTINE
lotions, oils, powders, and creamsProduct Information Item Code (Source) NHRIC:49520-902 Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) INGR COCO-BETAINE (UNII: 03DH2IZ3FY) INGR MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X) INGR CURDLAN (UNII: 6930DL209R) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR LIME JUICE (UNII: 6416LES0Y6) INGR COCONUT ACID (UNII: 40U37V505D) INGR SAFFLOWER ACID (UNII: Y788KS82OV) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR GLYCERYL LAURATE (UNII: Y98611C087) INGR LAURIC ACID (UNII: 1160N9NU9U) INGR GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) INGR SUCROSE COCOATE (UNII: 3H18P0UK73) INGR POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 09/24/2012 Part 3 of 4 CALM AFTER THE STORM
lotions, oils, powders, and creamsProduct Information Item Code (Source) NHRIC:49520-903 Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/30/2014 Part 4 of 4 SAFETY BLANKET
lotions, oils, powders, and creamsProduct Information Item Code (Source) NHRIC:49520-904 Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR STEARYL ALCOHOL (UNII: 2KR89I4H1Y) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/10/2014 Labeler - mybody (004460532)