HALE AND HUSH BROAD SPECTRUM SPF 30 SPF 30- zinc oxide cream

Hale and Hush Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Hale and Hush Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Eclectic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 13.50%

PURPOSE

Sunscreen

INDICATIONS & USAGE

* Help 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 th

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.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• 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 broad spectrum spf of 15 or higher and other sun protection measure including:
• limit time in the sun, especially from 10am to 2 pm
• wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine [(L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Bisabolol (L-alpha), Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglycery1-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

QUESTIONS

602-858-5814

haleandhush.com

Distributed by Eclectic Solutions LLC

4820 South Ash Ave #102

Tempe AZ 85282

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HALE AND HUSH BROAD SPECTRUM SPF 30  SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83677-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALIC ACID, L- (UNII: J3TZF807X5)
PEG-60 GLYCERYL STEARATE (UNII: 85O35YN6YY)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WITCH HAZEL (UNII: 101I4J0U34)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM LACTATE (UNII: TU7HW0W0QT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MACADAMIA OIL (UNII: 515610SU8C)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
SANDALWOOD (UNII: 3641YW25N2)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
BARLEY (UNII: 5PWM7YLI7R)
ALCOHOL (UNII: 3K9958V90M)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
LEVOMENOL (UNII: 24WE03BX2T)
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
FYTIC ACID (UNII: 7IGF0S7R8I)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83677-610-58	55 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/02/2018

Labeler - Eclectic Solutions LLC (068556928)