SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN- homosalate, octisalate, and zinc oxide lotion

SUN SHIELD BROAD SPECTRUM SPF 50 MATTE by

Drug Labeling and Warnings

SUN SHIELD BROAD SPECTRUM SPF 50 MATTE 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
Homosalate 10%	Sunscreen
Octisalate 5%	Sunscreen
Zinc Oxide 16.5%	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

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

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
• 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
• children under 6 months: Ask a doctor

Other information

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

Inactive ingredients

Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone

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

MATTE

Broad
Spectrum
SPF 50

Sunscreen
Lotion

Non-Comedogenic
Dermatologist Tested

Net wt. 3 oz (85 g)

INGREDIENTS AND APPEARANCE

SUN SHIELD BROAD SPECTRUM SPF 50 MATTE   SUNSCREEN
homosalate, octisalate, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	165 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
Hydroxyacetophenone (UNII: G1L3HT4CMH)
XANTHAN GUM (UNII: TTV12P4NEE)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Triethoxycaprylylsilane (UNII: LDC331P08E)
C15-19 Alkane (UNII: CI87N1IM01)
Disteardimonium Hectorite (UNII: X687XDK09L)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
Sorbitan Olivate (UNII: MDL271E3GR)
DIMETHICONE (UNII: 92RU3N3Y1O)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Candelilla Wax (UNII: WL0328HX19)
Yellow Wax (UNII: 2ZA36H0S2V)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-140-34	479 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2019
2	NDC: 62032-140-09	1 in 1 CARTON	07/15/2019
2		85 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 62032-140-05	28 g in 1 TUBE; Type 0: Not a Combination Product	07/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	07/15/2019

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss American CDMO, LLC		080170933	MANUFACTURE(62032-140)