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

Obagi by

Drug Labeling and Warnings

Obagi by is a Otc medication manufactured, distributed, or labeled by OMP, INC., Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium dioxide 4.9%	Sunscreen
Zinc oxide 4.7%	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 40 minutes of swimming or sweating
  • immediately after towel drying
  • 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, butyloctyl salicylate, cetyl dimethicone, dimethicone, styrene/acrylates copolymer, trimethylsiloxysilicate, dimethicone PEG-8 laurate, isohexadecane, butylene glycol, polysorbate 60, trisiloxane, arachidyl alcohol, polyhydroxystearic acid, hydrated silica, ceramide 3, ceramide 6-II, ceramide 1, niacinamide, cholesterol, phytosphingosine, PEG-100 stearate, glyceryl stearate, ascorbic acid, avena sativa (oat) kernel extract, arachidyl glucoside, beeswax, behenyl alcohol, benzyl alcohol, stearic acid, bisabolol, dipotassium glycyrrhizate, ethylhexylglycerin, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, pantothenic acid/yeast polypeptide, PEG-8, xanthan gum, polyaminopropyl biguanide, polymethyl methacrylate, alumina, potassium sorbate, retinyl palmitate, sodium lauroyl lactylate, carbomer, tocopheryl acetate, BHT, disodium EDTA, methicone, methylisothiazolinone, triethoxycaprylylsilane

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

OBAGI®

MEDICAL

Sun Shield

MINERAL

BROAD SPECTRUM SPF 50

[sun icon]

Sunscreen

Lotion

Water resistant

(40 minutes)

Non-comedogenic

Net wt. 3 oz. (85 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-810
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	4.165 g  in 85 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.995 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
ISOHEXADECANE (UNII: 918X1OUF1E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TRISILOXANE (UNII: 9G1ZW13R0G)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
NIACINAMIDE (UNII: 25X51I8RD4)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
OAT (UNII: Z6J799EAJK)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
YELLOW WAX (UNII: 2ZA36H0S2V)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
XANTHAN GUM (UNII: TTV12P4NEE)
POLIHEXANIDE (UNII: 322U039GMF)
ALUMINUM OXIDE (UNII: LMI26O6933)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-810-03	1 in 1 CARTON	10/01/2015	12/31/2020
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	10/01/2015	12/31/2020

Labeler - OMP, INC. (790553353)