MINERAL SUNSCREEN SPF 50- zinc oxide, titanium dioxide stick

MINERAL SUNSCREEN SPF 50 by

Drug Labeling and Warnings

MINERAL SUNSCREEN SPF 50 by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

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 liberally 15 minutes before sun exposure
• reapply:
  • after 80 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 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

• protect this product in this container from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

beeswax, butyloctyl salicylate, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, silica

Label

Topcare Everyday Mineral Sunscreen Stick SPF 50

NDC: 36800-956-28

1.5 oz (42 g)

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN SPF 50 
zinc oxide, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-956
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	47 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL ALCOHOL (UNII: 936JST6JCN)
CANDELILLA WAX (UNII: WL0328HX19)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
CERESIN (UNII: Q1LS2UJO3A)
WHITE WAX (UNII: 7G1J5DA97F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOSTEARIC ACID (UNII: X33R8U0062)
PARAFFIN (UNII: I9O0E3H2ZE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-956-28	42 g in 1 CONTAINER; Type 0: Not a Combination Product	10/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/19/2020

Labeler - TOPCO ASSOCIATES LLC (006935977)