GLO SKIN BEAUTY OIL FREE SPF 40- glo skin beauty oil free spf 40 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 7.5%

Octisalate 2.5%

Zinc Oxie 7.5%

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 eyes. Rinse with water to remove.
Stop use and ask a docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

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

Inactive ingredients

Aqua/Water/Eau, Isopropyl Palmitate, Ethylhexyl Stearate, Ethylhexyl Isononanoate, Cyclopentasiloxane, Cetearyl Glucoside, Dimethicone, Phenoxyethanol, Glycereth-26, Oleth-3 Phosphate, Allantoin, Triethoxycaprylylsilane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Panthenol, Butylene Glycol, PEG-7 Trimethylolpropane Coconut Ether, Sodium Hyaluronate, Tocopheryl Acetate, Ascorbyl Palmitate, Iodopropynyl Butylcarbamate

Other Information

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

Principal Display Panel

60541-100

GLO SKIN BEAUTY OIL FREE SPF 40 
glo skin beauty oil free spf 40 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERETH-26 (UNII: NNE56F2N14)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
ALLANTOIN (UNII: 344S277G0Z)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PANTHENOL (UNII: WV9CM0O67Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60541-1000-51 in 1 CARTON12/31/2017
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/31/2017
Labeler - Hayden Caleel LLC (011367468)

Revised: 12/2017
Document Id: 609f2b35-15f4-b5fc-e053-2a91aa0aca6e
Set id: 6b27a508-8669-418f-bcb2-61a35b79a3a8
Version: 1
Effective Time: 20171218
 
Hayden Caleel LLC