Label: MYBODY PROTECT AND SERVE SPF-30- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49520-302-32, 49520-302-52 - Packager: mybody
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated September 3, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- DO NOT USE
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MYBODY PROTECT AND SERVE SPF-30
zinc oxide lotionProduct 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)