Tubby Todd (as Pld) - Mineral Mist Spf 50 (73088-107)

Tubby Todd (as Pld) - Mineral Mist Spf 50 (73088-107)
SPL v4
SPL
SPL Set ID dca54a19-af25-ce47-e053-2a95a90a22db
Route
TOPICAL
Published
Effective Date 2025-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.4 g) Zinc Cation (15.7 g)
Inactive Ingredients
Beta-sitosterol Isocetyl Stearoyl Stearate Microcrystalline Cellulose Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Silicon Dioxide Sodium Gluconate Sodium Stearoyl Glutamate Tocopherol Water Coco Glucoside Anhydrous Citric Acid Aloe Vera Leaf Glycerin Propanediol Dicaprylyl Carbonate Aluminum Oxide Polyhydroxystearic Acid (2300 Mw) Bentonite .alpha.-bisabolol, (+)- Butyloctyl Salicylate C18-c21 Alkane Caprylhydroxamic Acid Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Form Cetostearyl Alcohol Isononyl Isononanoate Methyl Dihydroabietate Squalene Helianthus Annuus (sunflower) Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-14

Description

Titanium Dioxide 3.4% Zinc Oxide 15.7%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

Titanium Dioxide 3.4% Zinc Oxide 15.7%

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.

Section 43683-2

Warnings

Directions

Other Information

Inactive ingredients

Section 50565-1

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

Section 50566-9

• Stop use and ask a doctor if skin rash occurs.

Section 50567-7

• When using this product • keep out of eyes. Rinse with water to remove. • keep away from face to avoid inhaling • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 ̊F.

Section 50570-1

• Do not use on damage or broken skin.

Section 51945-4

Warnings

• For external use only.

Directions

• Spray liberally and spread evenly by hand 15 minutes before sun exposure.

• Hold 4-6 inches away from skin to apply

• Reapply

-after 80 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 the risk, regularly use a sunscreen with a broad spectrum SPF value 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

• Do not spray product directly on face.

• Children under 6 months of age: ask a doctor.

Questions?

Call us at (619) 894-6540

Other Information

• Protect this product from excessive heat and direct sun

• May stain some fabrics

• Do not use if quality seal is broken or missing

Active Ingredients

Titanium Dioxide 3.4%



Zinc Oxide 15.7%

Inactive Ingredient

Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Squalene, Tocopherol, Water


Structured Label Content

Uses (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.

Section 43683-2 (43683-2)

Warnings

Directions

Other Information

Inactive ingredients

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

• Stop use and ask a doctor if skin rash occurs.

Section 50567-7 (50567-7)

• When using this product • keep out of eyes. Rinse with water to remove. • keep away from face to avoid inhaling • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 ̊F.

Section 50570-1 (50570-1)

• Do not use on damage or broken skin.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

• For external use only.

Directions (DIRECTIONS)

• Spray liberally and spread evenly by hand 15 minutes before sun exposure.

• Hold 4-6 inches away from skin to apply

• Reapply

-after 80 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 the risk, regularly use a sunscreen with a broad spectrum SPF value 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

• Do not spray product directly on face.

• Children under 6 months of age: ask a doctor.

Questions? (QUESTIONS?)

Call us at (619) 894-6540

Other Information (OTHER INFORMATION)

• Protect this product from excessive heat and direct sun

• May stain some fabrics

• Do not use if quality seal is broken or missing

Active Ingredients (ACTIVE INGREDIENTS)

Titanium Dioxide 3.4%



Zinc Oxide 15.7%

Inactive Ingredient (INACTIVE INGREDIENT)

Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Squalene, Tocopherol, Water


Advanced Ingredient Data


Raw Label Data

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