Octinoxate by Hayden Caleel LLC OCTINOXATE lotion

Octinoxate by

Drug Labeling and Warnings

Octinoxate by is a Otc medication manufactured, distributed, or labeled by Hayden Caleel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 5%

Titanium Dioxide 10%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of the eyes. Rinse with water to remove.

Stop use and ask a doctor if skin 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
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months of age: Ask a doctor

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

Aqua (Water/Eau), Ethylhexyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Silica, Cyclopentasiloxane, Caprylic/Capric Triglyceride, HDI/Trimethylol Hexyllactone Crosspolymer, Butylene Glycol, Glycerin, Polyglyceryl-3 Diisostearate, Cyclohexasiloxane, Octyldodecanol, Octyldecyl Xyloside, PEG-30 Dipolyhydroxystearate, Silica Dimethyl Silylate, Phenoxyethanol, Hydroxyethylacrylate/Sodium Acryloydimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Caprylyl Glycol, Ethylhexyl Glycerin, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Polymethylsilsesquioxane, Dimethicone, Retinyl Palmitate (Vitamin A), Triethoxycaprylylsilane, Camellia Oleifera (Green Tea) Leaf Extract, Diamond Powder, (+/-):Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Questions or comments?

Call: 1.800.232.0398 M-F 9am-6pm MST

Principal Display Panel - 30 mL Carton Label

LUXE

LIQUID FOUNDATION

BROAD SPECTRUM SPF 18

ANTI-AGING

DIAMOND POWDER

TECHNOLOGY

glo·minerals

30 mL / 1 fl. oz.

INGREDIENTS AND APPEARANCE

OCTINOXATE 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60541-8407
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 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl Palmitate (UNII: 2865993309)
Neopentyl Glycol Dicaprylate/Dicaprate (UNII: VLW429K27K)
Tridecyl Trimellitate (UNII: FY36J270ES)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Glycerin (UNII: PDC6A3C0OX)
Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)
Octyldodecanol (UNII: 461N1O614Y)
Peg-30 Dipolyhydroxystearate (UNII: 9713Q0S7FO)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silica Dimethyl Silylate (UNII: EU2PSP0G0W)
Caprylyl Glycol (UNII: 00YIU5438U)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.S At 1%) (UNII: 86FQE96TZ4)
Isohexadecane (UNII: 918X1OUF1E)
Polysorbate 60 (UNII: CAL22UVI4M)
Ethylhexylglycerin (UNII: 147D247K3P)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Hexylene Glycol (UNII: KEH0A3F75J)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Camellia Oleifera Leaf (UNII: 5077EL0C60)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60541-8407-4	1 in 1 BOX
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2013

Labeler - Hayden Caleel LLC (011367468)

Establishment
Name	Address	ID/FEI	Business Operations
Hayden Caleel LLC		011367468	MANUFACTURE(60541-8407)