Toddle Mineral Spf 50 Sunscreen 1.7oz & 6oz

Toddle Mineral Spf 50 Sunscreen 1.7oz & 6oz
SPL v2
SPL
SPL Set ID 36af9a0a-536b-ee1a-e063-6394a90aace4
Route
TOPICAL
Published
Effective Date 2025-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Magnesium Sulfate Niacinamide Dimethicone Sorbitan Oleate Phenoxyethanol Hydrogenated Castor Oil Helianthus Annuus (sunflower) Seed Oil .alpha.-tocopherol Acetate Vp/hexadecene Copolymer Inulin Synthetic Beeswax Aloe Barbadensis Leaf Juice Butyloctyl Salicylate Caprylic/capric Triglyceride Dicaprylyl Carbonate Ethylhexylglycerin Isopropyl Myristate Water Butylene Glycol Ethylhexyl Methoxycrylene Xanthan Gum Sorbitan Olivate Cetearyl Olivate Polyglyceryl-3 Pentaricinoleate Polyhydroxystearic Acid Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-03

Description

Zinc Oxide 20.00%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

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

Apply evenly to face and neck 15 minutes beofre sun exposure.

Reapply:

  • After 40 minutes of swimming or sweating.
  • Immediately after towel drying
  • 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limin time in the sun, especially from 10a.m - 2p.m
  • Wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Description

Zinc Oxide 20.00%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs.

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

Aloe Barbadensis Leaf Juice

Butylene Glycol

Butyloctyl Salicylate

Caprylic/Capric Triglyceride

Cetearyl Olivate

Dicaprylyl Carbonate

Dimethicone

Ethylhexyl Methoxycrylene

Ethylhexylglycerin

Helianthus Annuus (Sunflower) Seed Oil

Hydrogenated Castor Oil

Inulin

Isopropyl Myristate

Magnesium Sulfate

Niacinamide

Phenoxyethanol

Polyglyceryl-3 Polyricinoleate

Polyhydroxystearic Acid

Sorbitan Oleate

Sorbitan Olivate

Synthetic Beeswax

Tocopheryl Acetate

VP/Hexadecene Copolymer

Water

Xanthan Gum

Section 51945-4

Section 53413-1

Questions?

[email protected]

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 20.00%

Section 60561-8

Protect this product from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

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)

Apply evenly to face and neck 15 minutes beofre sun exposure.

Reapply:

  • After 40 minutes of swimming or sweating.
  • Immediately after towel drying
  • 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limin time in the sun, especially from 10a.m - 2p.m
  • Wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

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)

Aloe Barbadensis Leaf Juice

Butylene Glycol

Butyloctyl Salicylate

Caprylic/Capric Triglyceride

Cetearyl Olivate

Dicaprylyl Carbonate

Dimethicone

Ethylhexyl Methoxycrylene

Ethylhexylglycerin

Helianthus Annuus (Sunflower) Seed Oil

Hydrogenated Castor Oil

Inulin

Isopropyl Myristate

Magnesium Sulfate

Niacinamide

Phenoxyethanol

Polyglyceryl-3 Polyricinoleate

Polyhydroxystearic Acid

Sorbitan Oleate

Sorbitan Olivate

Synthetic Beeswax

Tocopheryl Acetate

VP/Hexadecene Copolymer

Water

Xanthan Gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

[email protected]

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 20.00%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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