NDC 49520-502 Calm It Down Kit

NDC Product Code 49520-502

NDC 49520-502-64

Package Description: 1 KIT in 1 KIT

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Calm It Down Kit with NDC 49520-502 is a product labeled by Mybody. The generic name of Calm It Down Kit is . The product's dosage form is and is administered via form.

Labeler Name: Mybody

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mybody
Labeler Code: 49520
Start Marketing Date: 05-10-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Calm It Down Kit Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

ACTIVE INGREDIENTTITANIUM DIOXIDE 10.9%ZINC OXIDE 4.01%

Otc - Purpose

PURPOSESUNSCREEN

Indications & Usage

USE HELPS PROTECT AGAINST SUNBURN

Warnings

WARNINGSFOR EXTERNAL USE ONLY

Otc - When Using

  • WHEN USING THIS PRODUCTAVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.

Otc - Stop Use

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

Otc - 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.

Otc - Do Not Use

  • DO NOT USEON INFLAMED OR BROKEN SKIN.

Dosage & Administration

  • DIRECTIONSUSE 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 RESULTSCLEANSE 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 INFORMATIONSTORE AT ROOM TEMPERATUREAVOID HIGH TEMPERATURES AND PROTECT FROM FREEZING.DO NOT USE IF INNER SEAL IS BROKEN.SUN ALERTLIMITING 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.

Otc - Questions

QUESTIONS OR COMMENTS?CALL 877.423.1314 * WWW.LOVEMYBODY.COM

* Please review the disclaimer below.