SPL v4
SPL
SPL Set ID 0450dcc9-3f8f-e2c2-e063-6294a90af60b
Route
TOPICAL
Published
Effective Date 2023-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.0135 g)
Inactive Ingredients
Simmondsia Chinensis Seed Wax Lonicera Japonica Flower Ethyl Macadamiate Porphyra Umbilicalis Phellodendron Amurense Bark Glyceryl Isostearate .alpha.-tocopherol Acetate, D- Lecithin, Soybean Sodium Hydroxide Hydrogenated Palm Glycerides Alcohol Docosanol Hypromelloses Sodium Lactate Citric Acid Monohydrate Levomenol Sandalwood Lonicera Caprifolium Flower Potassium Cetyl Phosphate Cetostearyl Alcohol Water Glycerin Sodium Stearoyl Lactylate Polyhydroxystearic Acid (2300 Mw) Barley Isodecyl Neopentanoate Hydroxypropyl Corn Starch (5% Substitution By Weight) Macadamia Oil Fytic Acid Ergothioneine Glyceryl Monostearate Hamamelis Virginiana Top Water Medium-chain Triglycerides Rice Bran Candelilla Wax Polyglycerin-3 Polyglyceryl-10 Pentastearate Kukui Nut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-01 Until 2025-12-31

Description

Active Ingredient(s): Zinc Oxide (13.5%)


Medication Information

Warnings and Precautions

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. If the product is swallowed, get medical help or contact a Posion Control Center right away.
Indications and Usage

Uses:

  • Helps prevent sunburn
  • If used as directed with other protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Dosage and Administration

Directions:

  • Apply liberally 15 min before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor.
  • 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeve shirts, pants, hats, and sunglasses.
Description

Active Ingredient(s): Zinc Oxide (13.5%)

Section 50565-1
  • Keep out of reach of children. If the product is swallowed, get medical help or contact a Posion Control center right away.
Section 51727-6

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

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredient(s): Zinc Oxide (13.5%)

Section 60561-8

Other Information:

  • Protect the product from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Helps prevent sunburn
  • If used as directed with other protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Dosage and Administration (34068-7)

Directions:

  • Apply liberally 15 min before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor.
  • 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeve shirts, pants, hats, and sunglasses.
Warnings and Precautions (34071-1)

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. If the product is swallowed, get medical help or contact a Posion Control Center right away.
Section 50565-1 (50565-1)
  • Keep out of reach of children. If the product is swallowed, get medical help or contact a Posion Control center right away.
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredient(s): Zinc Oxide (13.5%)

Section 60561-8 (60561-8)

Other Information:

  • Protect the product from excessive heat and direct sun.

Advanced Ingredient Data


Raw Label Data

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