SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN- octinoxate 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 OMP, Inc., Ei INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 7.5%, Zinc Oxide 10.5%

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

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
• ▪ 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

1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum

Other information

• ▪ store at controlled room temperature: 15°C–25°C (59°F–77°F)
• ▪ 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

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

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
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	105 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PEG-40 STEARATE (UNII: ECU18C66Q7)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TROPOLONE (UNII: 7L6DL16P1T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-125-90	1 in 1 CARTON	02/21/2013
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 62032-125-05	15 g in 1 TUBE; Type 0: Not a Combination Product	02/21/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/21/2013

Labeler - OMP, Inc. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Ei INC.		105803274	MANUFACTURE(62032-125) , LABEL(62032-125) , PACK(62032-125)