NDC 63550-850 Sun Defense Spf 15

NDC Product Code 63550-850

NDC 63550-850-12

Package Description: 150 mL in 1 BOX

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

NDC Product Information

Sun Defense Spf 15 with NDC 63550-850 is a product labeled by Kamins Dermatologics Inc.. The generic name of Sun Defense Spf 15 is . The product's dosage form is and is administered via form.

Labeler Name: Kamins Dermatologics Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

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.

  • MALIC ACID (UNII: 817L1N4CKP)
  • DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
  • PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • ACER SACCHARUM SAP (UNII: 75UOH57984)
  • POMEGRANATE (UNII: 56687D1Z4D)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • ACAI (UNII: 46AM2VJ0AW)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
  • ALCOHOL (UNII: 3K9958V90M)

Product Labeler Information

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

Labeler Name: Kamins Dermatologics Inc.
Labeler Code: 63550
Start Marketing Date: 09-02-2011 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sun Defense Spf 15 Product Label Images

Sun Defense Spf 15 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 ingredients:Avobenzone 3%Homosalate 10%Octisalate 5%Oxybenzone 6%

Otc - Purpose

Purpose: Sunscreen

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

A broad spectrum UVA/UVB sunscreen to help protect the skin
from sunburn. Sun Defense Spray SPF 15 is enriched with moisturizing açai
oil, pomegranate extract and Bio-MapleTM compound to help skin
remain hydrated. Uses■ Helps prevent sunburn.■ Higher SPF gives more sunburn protection.■ Provides high protection against sunburn.

Warnings

WarningsFor external use only.When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.Stop use and ask a doctor if rash or irritation develops and lasts.If swallowed, seek medical assistance or contact a Poison Control
Center immediately.Flammable: Keep away from open flame or source of heat.  Do not use while smoking. Avoid long term storage above 40 °C (104°F)Other informationSun 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.

Dosage & Administration

Directions■ Apply 15-30 minutes before sun exposure.
■ Hold bottle 8-10 inches from the skin and press pump to spray a fine even
mist.■ Spray liberally and evenly over all exposed areas to ensure complete
coverage.■ Do not spray directly onto face; spray into hands, then immediately apply
to face.■ Rub into skin on all exposed areas.■ Reapply every two hours or as needed, after swimming, washing, towel
drying, or perspiring heavily.

Inactive Ingredient

Inactive ingredients: alcohol denat., ethyl macadamiate, tocopherol, malic acid, diethylhexyl 2,6-naphthalate, PPG-5-ceteth-20, acrylates/octylacrylamide copolymer, ethylene brassylate, lauryl PCA, tocopheryl acetate, acer saccharum (maple isolate), punica granatum (pomegranate) extract, propylene glycol, water, euterpe oleracea (acai) oil, retinyl palmitate, magnesium ascorbyl phosphate.

* Please review the disclaimer below.