O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, octocrylene, titanium dioxide, zinc oxide cream

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

Octisalate 2.5%

Octocrylene 4%

Titanium Dioxide 1.53%

Zinc Oxide 8.73%

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

• Do not use ​on damaged or broken skin

WHEN USING

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

STOP USE

• Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

• 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
• children under 6 months of age: 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

OTHER INFORMATION

• protect the product in this container from excessive heat and direct sun
• may stain some fabrics

INACTIVE INGREDIENTS

WATER, DICAPRYLYL CARBONATE, HEXYL LAURATE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, GLYCERIN, CYCLOPENTASILOXANE, ISOHEXADECANE, DISTEARDIMONIUM HECTORITE, PANTHENOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERYL CAPRYLATE, MAGNESIUM SULFATE, PEG-30 DIPOLYHYDROXYSTEARATE, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM STEARATE, ALUMINA, ETHYLHEXYLGLYCERIN, STEARYL GLYCYRRHETINATE, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, MORINGA OLEIFERA SEED OIL, DIPHENYLSILOXY PHENYL TRIMETHICONE, TOCOPHEROL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CHRYSIN, 1,2-HEXANEDIOL, CAMELLIA SINENSIS LEAF EXTRACT, HYDROXYCITRONELLAL, LIMONENE, LINALOOL, MICA, IRON OXIDES (CI 77491, CI 77492, CI 77499)

QUESTIONS?

1-866-993-4709

SPL UNCLASSIFIED SECTION

This moisturizing, tinted sunscreen with broad spectrum SPF 50 provides light and dewy coverage, leaving skin luminous.

MADE IN KOREA

DISTR. LG H&H Co., Ltd. 98 HUAM-RO, JUNG-GU, SEOUL, REPUBLIC OF KOREA.

PRINCIPAL DISPLAY PANEL

O HUI

DAY SHIELD

PERFECT SUN

BLACK

BROAD SPECTRUM SPF 50
SUNSCREEN

50 ml / 1.7 fl. oz.

INGREDIENTS AND APPEARANCE

O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN 
octisalate, octocrylene, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-651
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.73 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.53 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)
NUTMEG (UNII: AEE24M3MQ9)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PANTHENOL (UNII: WV9CM0O67Z)
MAGNESIUM SULFATE (UNII: DE08037SAB)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALUMINA (UNII: LMI26O6933)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
WATER (UNII: 059QF0KO0R)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CI 77491 (UNII: 1K09F3G675)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
LINALOOL, (+)- (UNII: F4VNO44C09)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CI 77492 (UNII: EX438O2MRT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHRYSIN (UNII: 3CN01F5ZJ5)
CI 77499 (UNII: XM0M87F357)
TOCOPHEROL (UNII: R0ZB2556P8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-651-50	1 in 1 BOX	05/26/2026
1		50 mL 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 Drug	M020	05/26/2026

Labeler - LG H&H Co., Ltd. (688276187)

Registrant - fmg Co.Ltd (690188305)

Establishment
Name	Address	ID/FEI	Business Operations
fmg Co.Ltd		690188305	manufacture(53208-651)