Tubby Todd (as PLD) - Mineral Sunscreen SPF-50 (73088-104) - DELIST

Mineral Sunscreen by

Drug Labeling and Warnings

Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by TUBBY TODD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL SUNSCREEN SPF-50- titanium dioxide, zinc oxide lotion 
TUBBY TODD

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Tubby Todd (as PLD) - Mineral Sunscreen SPF-50 (73088-104) - DELIST

ACTIVE INGREDIENTS

Titanium Dioxide 5%
Zinc Oxide 7%

PURPOSE

SUNSCREEN

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.

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.

DIRECTIONS

• Apply generously 15 minutes before sun exposure and as needed.
• 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 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 10 a.m.-2 p.m.
•      wear long-sleeved shirts, pants, hats, and sunglasses".

• Children under 6 months of age: ask a doctor

INACTIVE INGREDIENT

Water, Caprylic Capric Triglycerides, C12-C15 Alkyl Benzoate, Triethoxycaprylsilane, Glycerin, Propanediol, Dicaprylyl Ether, lsostearic Acid, Polyhydroxystearic Acid, Octyldodecyl Stearyl Citrate Crosspolymer, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Sodium Hyaluronate

MINERAL SUNSCREEN  SPF-50
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73088-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73088-104-14	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/21/2019	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/21/2019	12/31/2023

Labeler - TUBBY TODD (052545299)

Revised: 3/2024

Document Id: 14ab9203-49b6-8bef-e063-6394a90ae1e6

34390-5

Set id: 3517ba13-37a2-4677-bfef-55d53e705932

Version: 7

Effective Time: 20240327

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