MYBODY PROTECT AND SERVE SPF-30- zinc oxide lotion

myBody PROTECT AND SERVE by

Drug Labeling and Warnings

myBody PROTECT AND SERVE by is a Otc medication manufactured, distributed, or labeled by mybody. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

ZINCE OXIDE 13.5%

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.

OTHER SAFETY INFORMATION

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

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 décolletage. 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.

GENERAL PRECAUTIONS

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 INGREDIENT

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

QUESTIONS OR COMMENTS?

CALL 877.423.1314 * WWW.MYBODYSKINCARE.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYBODY PROTECT AND SERVE  SPF-30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49520-302
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49520-302-52	1 in 1 BOX
1	NDC: 49520-302-32	60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/03/2015

Labeler - mybody (004460532)

Registrant - mybody (004460532)