GLO SKIN BEAUTY SOLAR SHADE SPF 50 lotion

glo SKIN BEAUTY Solar Shade SPF 50 by

Drug Labeling and Warnings

glo SKIN BEAUTY Solar Shade SPF 50 by is a Otc medication manufactured, distributed, or labeled by Hayden Caleel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60541-1200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.5 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	8.6 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60541-1200-5	1 in 1 CARTON	12/31/2017
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/31/2017

Labeler - Hayden Caleel LLC (011367468)