FLUID FOUNDATION SPF 30 COLOR 01- avobenzone, octinoxate, octocrylene, and titanium dioxide cream

Fluid Foundation SPF 30 by

Drug Labeling and Warnings

Fluid Foundation SPF 30 by is a Otc medication manufactured, distributed, or labeled by ORLANE, Inc., Orlane, Orleans. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 1.5%	Sunscreen
Octinoxate 7%	Sunscreen
Octocrylene 5%	Sunscreen
Titanium dioxide 4.49%	Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use

• on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age : ask a doctor

Other information

protect the product in this container from excessive heat and direct sun.

Inactive ingredients

water, cyclopentasiloxane, isododecane, talc, alcohol denat., cetyl peg/ppg-10/1dimethicone, butylene glycol, isoamyl laurate, polyglyceryl-4 isostearate, nylon-12, disteardimonium hectorite, benzotriazolyl dodecyl p-cresol, benzyl alcohol, iron oxides, synthetic fluorphlogopite, polysorbate 20, tocopheryl acetate, phenoxyethanol, silica, hydrogen dimethicone, triethoxycaprylylsilane, disodium edta, dehydroacetic acid, cellulose, xanthan gum, hectorite, aluminum hydroxide, parfum (fragrance), sodium hyaluronate, ascorbyl tetraisopalmitate, biosaccharide gum-4, propanediol, evodia rutaecarpa fruit extract, geraniol.

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

ORLANE
PARIS

FLUID FOUNDATION SPF 30
SUN GLOW
SUNSCREEN

30 ml e
1 FL. OZ.

INGREDIENTS AND APPEARANCE

FLUID FOUNDATION SPF 30   COLOR 01
avobenzone, octinoxate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65371-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	25 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	62.5 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	238.7 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	238.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
TALC (UNII: 7SEV7J4R1U)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
NYLON-12 (UNII: 446U8J075B)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HECTORITE (UNII: 08X4KI73EZ)
XANTHAN GUM (UNII: TTV12P4NEE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
PROPANEDIOL (UNII: 5965N8W85T)
TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65371-054-01	1 in 1 CARTON	03/01/2016
1		30 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 FINAL	part352	03/01/2016

Labeler - ORLANE, Inc. (131360992)

Establishment
Name	Address	ID/FEI	Business Operations
Orlane, Orleans		578687469	MANUFACTURE(65371-054)