GLO SKIN BEAUTY SOLAR SHADE SPF 50- glo skin beauty solar shade spf 50 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.

----------

DRUG FACTS

Active Ingredients

Titanium Dioxide 6.5%

Zinc Oxide 8.6%

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, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Glycerin, Sodium Chloride, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Cetearyl Olivate, Sorbitan Olivate, Cyclohexasiloxane, Hexyl Laurate, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Dimethicone/Polyglycerin-3 Crosspolymer, Ascorbyl Palmitate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Ascorbic Acid, Citric Acid, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8

Other Information

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

Principal Display Panel

60541-1200

GLO SKIN BEAUTY SOLAR SHADE SPF 50 
glo skin beauty solar shade spf 50 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-1200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.5 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION8.6 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60541-1200-51 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: 60b2ba1f-d826-1b74-e053-2a91aa0ab0ee
Set id: 6423330c-2102-41cb-a013-a030f4f34eef
Version: 1
Effective Time: 20171219
 
Hayden Caleel LLC