MINERAL SUNSCREEN- zinc oxide spf 50 cream

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]

Drug Facts

Active ingredients

Zinc Oxide 19.6%

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 liberally 15 minutes before sun exposure.
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 valuor 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

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Ethylhexylglycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN 
zinc oxide spf 50 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73088-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
WATER (UNII: 059QF0KO0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
BISABOLOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID (UNII: 2968PHW8QP)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
CELLULOSE GUM (UNII: K679OBS311)
COCO-GLUCOSIDE (UNII: ICS790225B)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73088-109-14	118 mL in 1 TUBE; Type 0: Not a Combination Product	12/17/2024
2	NDC: 73088-109-05	5 mL in 1 PACKET; Type 0: Not a Combination Product	12/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/17/2024

Labeler - Tubby Todd (052545299)