SUNSCREEN- titanium dioxide 6.8% liquid

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by Baxter of California, LLC, Dimensional Merchandising, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octisalate 3.2%

Octocrylene 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 damamged skin or broken skin

When using this product

Keep out of eyes.

Rinse with water to remove

Stop use and ask doctor if

rash occurs

Keep out of reach of children

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

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 10am-2pm
  • wear long sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, undecane, dimethicone, glycerin, tridecane, polyglyceryl-4 isostearate, pentylene
glycol, cetyl PEG/PPG-10/1, hexyl laurate, magnesium sulfate, disteardimonium hectorite,
trihydroxystearin, cellulose gum, aluminum hydroxide, disodium stearoyl glutamate,
acetylated glycol stearate, acrylates copolymer, ethylhexylglyceerin; may contain:
titanium dioxide, iron oxides

Questions or Comments?

1-877-900-6700
Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN 
titanium dioxide 6.8% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84203-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.068 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
UNDECANE (UNII: JV0QT00NUE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
TRIDECANE (UNII: A3LZF0L939)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ACETYLATED GLYCOL STEARATE (UNII: K71M6R9N7E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84203-001-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/25/2024

Labeler - Baxter of California, LLC (031183172)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising, Inc		076693183	manufacture(84203-001)