SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide and zinc oxide lotion

SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium dioxide 6.2%	Sunscreen
Zinc oxide 15.6%	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
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: 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

Inactive ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Pentylene Glycol, Steareth-2, Glycerin, Silica, Polyhydroxystearic Acid, Steareth-21, Cetearyl Alcohol, Propanediol, Alumina, Stearic Acid, Sodium Stearoyl Glutamate, Caprylyl Glycol, Triethoxycaprylylsilane, Cetearyl Glucoslde, Xanthan Gum, Dipotassium Glycyrrhizate, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Tropaeolum Majus Flower/Leaf/Stem Extract

Other information

• store at controlled room temperature: 15ºC–25ºC (59ºF–77ºF)
• protect this product from excessive heat and direct sun

Questions or comments?

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

OBAGI™
MEDICAL

Sun Shield
MINERAL
Broad
Spectrum
SPF 50

Sunscreen
Lotion

PA++++
Non-comedogenic
Dermatologist Tested

Net wt. 3 oz. (85 g)

INGREDIENTS AND APPEARANCE

SUN SHIELD MINERAL BROAD SPECTRUM SPF 50   SUNSCREEN
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-811
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	6.2 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	15.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TROPAEOLUM MAJUS FLOWERING TOP (UNII: RGT30824HY)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-811-09	1 in 1 CARTON	12/01/2019
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/01/2019

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	MANUFACTURE(62032-811)