ADVANCED PROTECTION- octinoxate and zinc oxide cream

Advanced Protection by

Drug Labeling and Warnings

Advanced Protection by is a Otc medication manufactured, distributed, or labeled by CBI Laboratories, Inc, CBI Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 7.5%	sunscreen
Zinc Oxide 5%	sunscreen

Uses

• provides moderate sun protection

Warnings

• for external use only
• for adult use only

When using this product

• keep out of eyes. If contact occurs rinse with water to remove.

• Stop use if irritation occurs.

• Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

• Apply liberally 20 minutes before sun exposure and reapply as needed.
• Children under 6 months of age: ask a physician.

Inactive ingredients

Beeswax, Bis-PEG-12 Dimethicone, Butylparaben, C13-14 Isoparaffin, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Chrondrus Crispus (Carrageenan), Copernicia Cerifera (Carnauba) Wax, Cyclomethicone, Dicaprylyl Maleate, Dimethicone, Ethylparaben, Glycol Stearate, Glycyrrhiza Glabra (Licorice) Extract, Isobutylparaben, Laureth-7, Lecithin, Methylparaben, PEG-100 Stearate, PEG-20, Phenoxyethanol, Plankton Extract, Polyacrylamide, Propylparaben, Sorbitan Tristearate, Steareth-100, Stearyl Alcohol, Synthetic Beeswax, Tocopheryl Acetate, VP/Eicosene Copolymer, Water (Aqua), Xanthan Gum

PRINCIPAL DISPLAY PANEL - 56.7 g Carton

Moisture Defense
SPF 15

Net Wt 2 Oz/56.7 g

INGREDIENTS AND APPEARANCE

ADVANCED PROTECTION   SPF-15
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24623-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
CYCLOMETHICONE (UNII: NMQ347994Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIOCTYL MALEATE (UNII: OD88G8439L)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCOL STEARATE (UNII: 0324G66D0E)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24623-001-20	56.7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/25/2001

Labeler - CBI Laboratories, Inc (623704368)

Establishment
Name	Address	ID/FEI	Business Operations
CBI Laboratories		623704368	MANUFACTURE