EX-GLOW-SION SPF-20- titanium dioxide, zinc oxide lotion

EX-GLOW-SION by

Drug Labeling and Warnings

EX-GLOW-SION by is a Otc medication manufactured, distributed, or labeled by HATCHBEAUTY PRODUCTS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 5.75%

ZINC OXIDE 3.70%

PURPOSE

SUNSCREEN

USES

HELPS PREVENT SUNBURN

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 DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake well before use
• Apply generously to face 15 minutes before sun exposure.
• Children under 6 months of age: ask a doctor.
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early 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.
       Reapply at least every 2 hours.
       Use a water resistant sunscreen if swimming or sweating; immediately after towel drying.

Inacitve Ingredients

Water/Aqua/Eau, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, Propylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone,  Isononyl Isononanoate, Silica, Butylene Glycol, Trimethylsiloxysilicate, Argania Spinosa Kernel Oil, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Alcohol Denat., Quaternium-18 Hectorite, Glycerin, Prunus Persica (Peach) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Oenothera Biennis (Evening Primrose) Flower/Leaf/Stem Extract, Jasminum Officinale (Jasmine) Flower Extract, Amaranthus Caudatus Seed Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Ceramide 3, Niacinamide, Bisabolol, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Sodium Chloride, Xanthan Gum, Sucrose Palmitate, Maltodextrin, Perfluorodecalin, Pyridoxine HCl, Calcium Pantothenate, Synthetic Fluorphlogopite, Polysorbate 20, Triethoxycaprylylsilane, Bis-Phenylpropyl Dimethicone, Sodium Starch Octenylsuccinate, Ethylhexylglycerin,
Ethylbisiminomethylguaiacol Manganese Chloride, Phenoxyethanol. May Contain: Iron Oxides (CI 77491/77492/77499).

OTHER INFORMATION

PROTECT THIS PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EX-GLOW-SION  SPF-20
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69863-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
SILICON (UNII: Z4152N8IUI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ARGAN OIL (UNII: 4V59G5UW9X)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
QUATERNIUM-18 HECTORITE (UNII: IIS3YBV1XX)
GLYCERIN (UNII: PDC6A3C0OX)
PEACH JUICE (UNII: K37IH01KN1)
VITIS VINIFERA WHOLE (UNII: 22E66I250J)
OENOTHERA BIENNIS (UNII: 76UI55V071)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
AMARANTHUS CAUDATUS SEED (UNII: FJ722PPQ9M)
JOJOBA OIL (UNII: 724GKU717M)
CERAMIDE 3 (UNII: 4370DF050B)
NIACINAMIDE (UNII: 25X51I8RD4)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PERFLUNAFENE (UNII: 54A06VV62N)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69863-103-51	1 in 1 BOX
1	NDC: 69863-103-11	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 69863-103-12	7 mL 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	12/16/2015

Labeler - HATCHBEAUTY PRODUCTS LLC (044612361)

Registrant - HATCHBEAUTY PRODUCTS LLC (044612361)