GLO SKIN BEAUTY TINTED PRIMER SPF 30- glo skin beauty tinted primer spf 30 cream 
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

Titanium Dioxide 4.5%

Zinc Oxide 4%

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

Isododecane, Cyclopentasiloxane, Cylcohexasiloxane, Polysilicone-11, Mica, Polymethylsilsesquioxane, Hexyl Laurate, Polyglyceryl-3 Diisostearate, PEG/PPG-20/15 Dimethicone, Triethoxycaprylylsilane, Dimethicone, Iron Oxides

Other Information

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

Principal Display Panel

60541-1400-3

GLO SKIN BEAUTY TINTED PRIMER SPF 30 
glo skin beauty tinted primer spf 30 cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-1400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60541-1400-31 in 1 CARTON12/31/2017
130 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: 60ded7af-5533-227a-e053-2a91aa0addb5
Set id: 3f3c4148-d66c-4e94-a20f-12725fa960cf
Version: 1
Effective Time: 20171221
 
Hayden Caleel LLC