OCTINOXATE- octinoxate lotion 
Hayden Caleel LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Octinoxate 5%

Titanium Dioxide 10%

Purpose

Sunscreen

Uses

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

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

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.

Principal Display Panel - 30 mL Carton Label
OCTINOXATE 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-8407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60541-8407-41 in 1 BOX
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2013
Labeler - Hayden Caleel LLC (011367468)
Establishment
NameAddressID/FEIBusiness Operations
Hayden Caleel LLC011367468MANUFACTURE(60541-8407)

Revised: 8/2013
Document Id: 332c5fb6-263c-4b12-b37b-59a80c19c71e
Set id: 3a4e17fb-22c8-4c79-a140-17000ff13802
Version: 2
Effective Time: 20130827
 
Hayden Caleel LLC