SUN SHIELD MINERAL UV BARRIER PROTECT BROAD SPECTRUM SPF 40 SUNSCREEN- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 9.4%

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

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 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 10 a.m.–2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of of age: ask a doctor

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

aqua/water/eau, C12-15 alkyl benzoate, butyloctyl salicylate, propanediol, cetyl PEG/PPG-10/1 dimethicone, isododecane, methyl trimethicone, caprylic/ capric triglyceride, PEG-30 dipolyhydroxystearate, silica, glycerin, polyglyceryl-3 diisostearate, squalane, phenoxyethanol, magnesium sulfate, sodium chloride, stearalkonium hectorite, ethyl ferulate, triethoxycaprylylsilane, ethylhexylglycerin, sodium lauroyl lactylate, ceramide NP, ceramide AP, phytosphingosine, cholesterol, xanthan gum, carbomer, sr-(spider polypeptide-1 oligopeptide-178), tocopherol, ceramide EOP.

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 - 50 mL Bottle Carton

OBAGI®
MEDICAL

SUN SHIELD™

Mineral UV
Barrier Protect
Broad Spectrum SPF 40
Sunscreen Lotion

ceramides, squalane

SPF 40

1.7 fl. oz. / 50 mL

INGREDIENTS AND APPEARANCE

SUN SHIELD MINERAL UV BARRIER PROTECT BROAD SPECTRUM SPF 40 SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ISODODECANE (UNII: A8289P68Y2)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SQUALANE (UNII: GW89575KF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
ETHYL FERULATE (UNII: 5B8915UELW)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TOCOPHEROL (UNII: R0ZB2556P8)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-002-07	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2026
2	NDC: 62032-002-41	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	04/28/2026

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Dermaceutical Laboratories		080375664	MANUFACTURE(62032-002)