Kidzgoo Natural Sunscreen

Kidzgoo Natural Sunscreen
SPL v1
SPL
SPL Set ID c8c251e1-ab0b-edba-e053-2995a90abfd4
Route
TOPICAL
Published
Effective Date 2021-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (98.56 g)
Inactive Ingredients
Styrene/acrylamide Copolymer (mw 500000) Panthenol Silicon Dioxide Water Phenoxyethanol Cetostearyl Alcohol Phytate Sodium Xanthan Gum Alpha-tocopherol Acetate Polyhydroxystearic Acid (2300 Mw) Cetearyl Olivate Stearyl/octyldodecyl Citrate Crosspolymer Caprylyl Glycol Sorbitan Olivate Coco-caprylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-07-30

Description

Active Ingredient Zinc Oxide


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 swallowed, get medical help or contact a Poison Control Center right away.
Indications and Usage

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.
Dosage and Administration

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply;
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
Description

Active Ingredient Zinc Oxide

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive Ingredients:

Benzyl Alcohol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Coco-Caprylate, Dehydroacetic Acid, Deionized Water, Isostearic Acid, Lecithin, Microcrystalline Cellulose, Panthenol, Polyglyceryl-3, Polyhydroxystearic Acid, Silica, Sodium Phytate, Sorbitan Olivate, Stearyl Octyldodecyl Citrate Crosspolymer, Tocopherol, Xantan Gum

Section 51945-4

Section 53413-1

855-KIDZGOO

Melearning Media LLC

Upper Dublin, PA

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredient

Zinc Oxide

Section 60561-8

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 value of SPF 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


Structured Label Content

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply;
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
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 swallowed, get medical help or contact a Poison Control Center right away.
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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive Ingredients:

Benzyl Alcohol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Coco-Caprylate, Dehydroacetic Acid, Deionized Water, Isostearic Acid, Lecithin, Microcrystalline Cellulose, Panthenol, Polyglyceryl-3, Polyhydroxystearic Acid, Silica, Sodium Phytate, Sorbitan Olivate, Stearyl Octyldodecyl Citrate Crosspolymer, Tocopherol, Xantan Gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

855-KIDZGOO

Melearning Media LLC

Upper Dublin, PA

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide

Section 60561-8 (60561-8)

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 value of SPF 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


Advanced Ingredient Data


Raw Label Data

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