Tubby Todd - (s)undercover Spf-50 (73088-106)

Tubby Todd - (s)undercover Spf-50 (73088-106)
SPL v4
SPL
SPL Set ID dca478a0-c319-68d8-e053-2a95a90a10fc
Route
TOPICAL
Published
Effective Date 2022-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (12 g)
Inactive Ingredients
Allantoin Hydrolyzed Jojoba Esters Sodium Hydroxide Tocopherol Water Medium-chain Triglycerides Alkyl (c12-15) Benzoate Caprylyl Glycol Coco-caprylate Helianthus Annuus Whole Hydrogenated Jojoba Oil/jojoba Oil, Randomized (iodine Value 40-44) Lecithin, Sunflower Phenylpropanol Polyglyceryl-2 Dipolyhydroxystearate Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Propanediol Rosmarinus Officinalis Whole Silicon Dioxide Sodium Chloride Tetrasodium Glutamate Diacetate Nylon-12 Rice Bran Bisabolol Niacinamide Tridecyl Salicylate Polyglyceryl-3 Pentaricinoleate Methylpropanediol Stearalkonium Hectorite Polyglyceryl-3 Diisostearate

Identifiers & Packaging

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

Description

Zinc Oxide 12%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

Zinc Oxide 12%

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 50565-1

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

Section 51945-4

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.

Questions

(619) 894-6560

Directions
  • Apply generously 15 minutes before sun exposure and as needed.
  • Reapply
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Children under 6 months of age: 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10am-2pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information
  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Active Ingredients

Zinc Oxide 12%

Inactive Ingredient

Allantoin, Bisabolol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Coco-Caprylate, Helianthus Annuus (Sunflower) Extract, Jojoba Esters, Lecithin, Methylpropanediol, Niacinamide, Nylon-12, Orza Sativa (Rice) Bran Extract, Phenylpropanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Sodium Chloride, Sodium Hydroxide, Stearalkonium Hectorite, Tetrasodium Glutamate Diacetate, Tocopherol, Tridecyl Salicylate, 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 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SUNSCREEN

Warnings (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.

Questions (QUESTIONS)

(619) 894-6560

Directions (DIRECTIONS)
  • Apply generously 15 minutes before sun exposure and as needed.
  • Reapply
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Children under 6 months of age: 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10am-2pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information (OTHER INFORMATION)
  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Active Ingredients (ACTIVE INGREDIENTS)

Zinc Oxide 12%

Inactive Ingredient (INACTIVE INGREDIENT)

Allantoin, Bisabolol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Coco-Caprylate, Helianthus Annuus (Sunflower) Extract, Jojoba Esters, Lecithin, Methylpropanediol, Niacinamide, Nylon-12, Orza Sativa (Rice) Bran Extract, Phenylpropanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Sodium Chloride, Sodium Hydroxide, Stearalkonium Hectorite, Tetrasodium Glutamate Diacetate, Tocopherol, Tridecyl Salicylate, Water


Advanced Ingredient Data


Raw Label Data

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