TINTED MOISTURIZER SPF20- octinoxate and titanium dioxide cream

Tinted Moisturizer SPF20 by

Drug Labeling and Warnings

Tinted Moisturizer SPF20 by is a Otc medication manufactured, distributed, or labeled by CBI Laboratories, Inc, CBI Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 5%	sunscreen
Titanium Dioxide 4.2%	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

Aluminum Hydroxide, Aluminum Starch Octenylsuccinate, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Wax, Iron Oxides (CI 77492,77491, 77499), Magnesium Sulfate, Microcrystalline Wax, Polyglyceryl-4 Diisostearate, Polyglyceryl-4 Isostearate, Polyhydroxystearate Sebacate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Stearic Acid, Titanium Dioxide (CI 77891), Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Water (Aqua)

PRINCIPAL DISPLAY PANEL - 48.2 g Carton

skin-perfecting
tinted moisturizer

SPF 20

SUNCARE
ESSENTIALS

medium

Net Wt. 1.7 Oz / 48.2 g

INGREDIENTS AND APPEARANCE

TINTED MOISTURIZER SPF20   MEDIUM
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24623-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.042 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
EDETATE DISODIUM (UNII: 7FLD91C86K)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24623-048-17	48.2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/01/2007

Labeler - CBI Laboratories, Inc (623704368)

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