SPF 60 MINERAL SUNSCREEN- titanium dioxide, zinc oxide stick

SPF 60 Mineral Sunscreen by

Drug Labeling and Warnings

SPF 60 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 6%, Zinc Oxide 4.6%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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 or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Apply liberally 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 value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10:00 a.m. - 2:00 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Aluminum hydroxide, beeswax, BHT, butyloctyl salicylate, C12-15 alkyl benzoate, cetyl alcohol, dimethicone, euphoria cerifera (candelilla) wax, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, polyethylene, stearic acid, triethoxycaprylysilane

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 60 MINERAL SUNSCREEN 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-547
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CANDELILLA WAX (UNII: WL0328HX19)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
CERESIN (UNII: Q1LS2UJO3A)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE 200 (UNII: RGS4T2AS00)
ISOSTEARIC ACID (UNII: X33R8U0062)
PARAFFIN (UNII: I9O0E3H2ZE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-547-01	14 g in 1 CYLINDER; Type 0: Not a Combination Product	05/23/2023
2	NDC: 72839-547-11	14 g in 1 CYLINDER; Type 0: Not a Combination Product	05/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/23/2023

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(72839-547)