Label: O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, octocrylene, titanium dioxide, zinc oxide cream
- NDC Code(s): 53208-650-50
- Packager: LG H&H Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 31, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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, MICA, ETHYLHEXYLGLYCERIN, STEARYL GLYCYRRHETINATE, IRON OXIDES(CI 77492), MYRISTICA FRAGRANS (NUTMEG) EXTRACT, IRON OXIDES(CI 77491), IRON OXIDES(CI 77499), MORINGA OLEIFERA SEED OIL, DIPHENYLSILOXY PHENYL TRIMETHICONE, TOCOPHEROL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CHRYSIN, 1,2-HEXANEDIOL, CAMELLIA SINENSIS LEAF EXTRACT
- QUESTIONS?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN
octisalate, octocrylene, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-650 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 WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-650-50 2 in 1 BOX 03/31/2023 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 final M020 03/31/2023 Labeler - LG H&H Co., Ltd. (688276187) Registrant - fmg Co.Ltd (690188305) Establishment Name Address ID/FEI Business Operations fmg Co.Ltd 690188305 manufacture(53208-650)
