MYBODY PROTECT AND SERVE SPF-30- zinc oxide lotion 
mybody

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

ZINCE OXIDE 13.5%

PURPOSE

SUNSCREEN

USE

HELPS PROTECT AGAINST SUNBURN

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

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

KEEP OUT OF REACH OF CHILDREN.

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

STORE AT ROOM TEMPERATURE.

AVOID HIGH TEMPERATURES AND PROTECT FROM FREEZING.

DO NOT USE IF INNER SEAL IS BROKEN.

DO NOT USE

Directions

6 months of age: ask a doctor.

SUN ALERT

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

Inactive Ingredients Water/Aqua/Eau, C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Polysorbate 60, Cetyl Alcohol,
Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Caprylic/Capric Triglyceride,Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Polyhydroxystearic Acid, Caprylyl Glycol, Sclerotium Gum, Hamamelis Virginiana (Witch Hazel) Water, Alcohol, Xanthan Gum, Phytic Acid, Citric Acid.

QUESTIONS OR COMMENTS?

CALL 877.423.1314 * WWW.MYBODYSKINCARE.COM

ProtectServe-Sun Shield-No Tint-Spf 30-08-04-15_p1

MYBODY PROTECT AND SERVE  SPF-30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49520-302
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49520-302-521 in 1 BOX
1NDC:49520-302-3260 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/03/2015
Labeler - mybody (004460532)
Registrant - mybody (004460532)

Revised: 9/2015
Document Id: b09bf60f-15c1-44bf-9511-7aa909ed075c
Set id: cef96bec-57c1-4d8a-ad04-0007c128bfb4
Version: 1
Effective Time: 20150903
 
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