Otc - Active Ingredient
ACTIVE INGREDIENT
ZINCE OXIDE 13.5%
The following Structured Product Label (SPL) was submitted to the FDA by Mybody for the product Mybody Protect And Serve (NDC 49520-302). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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