TINTED MINERAL SUNSCREEN SPF 50- zinc oxide and titanium dioxide lotion

Tinted Mineral Sunscreen by

Drug Labeling and Warnings

Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient	Purpose
Zinc Oxide 11%	Sunscreen
Titanium Dioxide 7.5%	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.

When using this product keep out of eyes, rinse with water to remove.

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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 of 15 or higher and other sunscreen measures including:

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

Directions

• Apply liberally to face and neck and spread evenly 15 minutes before sun exposure
• Re-apply after swimming, excessive perspiring, or anytime after towel drying
• Use a water resistant sunscreen if swimming or sweating
• Use on children under 6 months of age: consult a doctor.

Inactive ingredients

Purified Water, Dimethicone, Methyl Trimethicone, Isononyl Isononanoate, Oleth-3 Phosphate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Alumina, Butylene Glycol, Octyldodecyl Neopentanoate, VP/Eicosene Copolymer, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Polyisobutene, Iron Oxides, Sucrose, Glycerin, Silicone, Isopropyl Titanium Triisostearate, Polysorbate 20, Polyacrylate-13, Panthenol, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-20 Phosphate, PEG-8 Methyl Ether Triethoxysilane, Hydrogen Dimethicone Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 99 g Bottle Label

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

MULTI-TASKING

Mineral
Lightly Tinted
Antioxidant
Sunscreen
SPF 50+

Broad Spectrum SPF 50+
Water Resistant 40 minutes

Net wt. 3.5 oz. (99 g)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

INGREDIENTS AND APPEARANCE

TINTED MINERAL SUNSCREEN   SPF 50
zinc oxide and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	110 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAFFEINE (UNII: 3G6A5W338E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
TRIETHOXYSILANE (UNII: 8T460WDH89)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-123-03	99 g in 1 BOTTLE; Type 0: Not a Combination Product	11/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	11/10/2020

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-123)