CALM IT DOWN KIT- titanium dioxide, zinc oxide 
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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.

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ACTIVE INGREDIENT

TITANIUM DIOXIDE 10.9%

ZINC OXIDE 4.01%

PURPOSE

SUNSCREEN

USE HELPS PROTECT AGAINST SUNBURN

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DO NOT USE

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

OTHER INFORMATION

SUN ALERT

LIMITING SUN EXPOSURE, WEARING PRODUCTIVE CLOTHING, AND USING SUNSCREEN MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER AND OTHER HARMFUL EFFECTS OF THE SUN.

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 OR COMMENTS?

CALL 877.423.1314 * WWW.LOVEMYBODY.COM

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CALM IT DOWN KIT 
titanium dioxide, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49520-502
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49520-502-641 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 2
Part 3
Part 4
Part 1 of 4
PROTECT AND SERVE  TINTED SUN SHIELD SPF 30
titanium dioxide and zinc oxide lotion
Product Information
Item Code (Source)NDC:49520-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE11 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/23/2012
Part 2 of 4
CLEAN ROUTINE 
lotions, oils, powders, and creams
Product Information
Item Code (Source)NHRIC:49520-902
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
INGRCOCO-BETAINE (UNII: 03DH2IZ3FY)  
INGRMYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
INGRCURDLAN (UNII: 6930DL209R)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRLIME JUICE (UNII: 6416LES0Y6)  
INGRCOCONUT ACID (UNII: 40U37V505D)  
INGRSAFFLOWER ACID (UNII: Y788KS82OV)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRGLYCERYL LAURATE (UNII: Y98611C087)  
INGRLAURIC ACID (UNII: 1160N9NU9U)  
INGRGUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
INGRSUCROSE COCOATE (UNII: 3H18P0UK73)  
INGRPOTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic09/24/2012
Part 3 of 4
CALM AFTER THE STORM 
lotions, oils, powders, and creams
Product Information
Item Code (Source)NHRIC:49520-903
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/30/2014
Part 4 of 4
SAFETY BLANKET 
lotions, oils, powders, and creams
Product Information
Item Code (Source)NHRIC:49520-904
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/10/2014
Labeler - mybody (004460532)

Revised: 6/2014
Document Id: 10847989-96c6-427a-82d3-1ac9121c4beb
Set id: 0430bf68-ee36-4762-a245-ec280cb480a5
Version: 1
Effective Time: 20140630
 
mybody