hale and hush broad spectrum spf 30

hale and hush broad spectrum spf 30
SPL v4
SPL
SPL Set ID 0530904f-b02c-d8cf-e063-6294a90aa5a7
Route
topical
Published
Effective Date 2018-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (13.5 g)
Inactive Ingredients
polyglyceryl-10 stearate phellodendron amurense bark lecithin, soybean malic acid, l- peg-60 glyceryl stearate polyhydroxystearic acid (2300 mw) .alpha.-tocopherol acetate, d- witch hazel docosanol sodium lactate citric acid monohydrate macadamia oil caprylic/capric/lauric triglyceride isodecyl neopentanoate aleurites moluccana seed porphyra umbilicalis glyceryl isostearate potassium cetyl phosphate hypromelloses ergothioneine sandalwood glycerin water barley alcohol lonicera caprifolium flower cetostearyl alcohol hydrogenated palm glycerides levomenol hydroxypropyl corn starch (5% substitution by weight) ethyl macadamiate sodium stearoyl lactylate fytic acid sodium hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2018-04-02

Description

Zinc Oxide 13.50%


Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Zinc Oxide 13.50%

Indications and 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

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
Description

Zinc Oxide 13.50%

Section 50565-1

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

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

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

Section 51945-4

Section 53413-1

602-858-5814

haleandhush.com

Distributed by Eclectic Solutions LLC

4820 South Ash Ave #102

Tempe AZ 85282

Section 55105-1

Sunscreen

Section 60561-8

Protect this product from excessive heat and direct sun


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Zinc Oxide 13.50%

Indications and Usage (34067-9)

* 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

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
Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

602-858-5814

haleandhush.com

Distributed by Eclectic Solutions LLC

4820 South Ash Ave #102

Tempe AZ 85282

Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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