CALM IT DOWN KIT- titanium dioxide, zinc oxide kit

CALM IT DOWN KIT by

Drug Labeling and Warnings

CALM IT DOWN KIT by is a Otc medication manufactured, distributed, or labeled by mybody. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

TITANIUM DIOXIDE 10.9%

ZINC OXIDE 4.01%

PURPOSE

PURPOSE

SUNSCREEN

INDICATIONS & USAGE

USE HELPS PROTECT AGAINST SUNBURN

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

WHEN USING THIS PRODUCT

• AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DO NOT USE

DO NOT USE

• ON INFLAMED OR BROKEN SKIN.

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

OTHER INFORMATION

• STORE AT ROOM TEMPERATURE
• AVOID HIGH TEMPERATURES AND PROTECT FROM FREEZING.
• DO NOT USE IF INNER SEAL IS BROKEN.

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 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

QUESTIONS OR COMMENTS?

CALL 877.423.1314 * WWW.LOVEMYBODY.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALM IT DOWN KIT 
titanium dioxide, zinc oxide kit

Product 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 lotion

Product 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 creams

Product 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 creams

Product 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 creams

Product 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)