OTC Medication Information: O HUI Perfect Sun Black EX Broad Spectrum SPF 50

O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50- titanium dioxide, ensulizole, octinoxate, octisalate and zinc oxide cream
LG Household and Health Care Inc

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.

ENSULIZOLE 3.5%, OCTINOXATE 7.0%, OCTISALATE 4.5%, TITANIUM DIOXIDE 4.4%, ZINC OXIDE 9.71%

PURPOSE

Sunscreen

USES

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), may decrease 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 the eyes. Rinse with water to remove.

Stop use and ask doctor , if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or

contact a Posion 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.
  • 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 othersun protection measures including:

– Limit time in the sun, especially from 10 a.m. to 2 p.m.

– Wear longsleeved shirts, pants, hats, and sunglasses.

  • Children under 6 months: Ask a doctor.

OTHER INFORMATION

  • Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, PANTHENOL, CHRYSIN, GALANTHUS NIVALIS SEED EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), FRAGRANCE

PRINCIPAL DISPLAY PANEL

O HUI Perfect Sun Black EX

Sunscreen Broad Spectrum SPF 50+

1.69 fl oz / 50 ml

box
(click image for full-size original)
O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50
ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-604
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.2 g in 50 g
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 1.75 g in 50 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.5 g in 50 g
OCTISALATE (OCTISALATE) OCTISALATE 2.25 g in 50 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 4.86 g in 50 g
Inactive Ingredients
Ingredient Name Strength
DISTEARDIMONIUM HECTORITE
WATER
DIPROPYLENE GLYCOL
TROMETHAMINE
STEARIC ACID
ALUMINUM HYDROXIDE
SORBITAN SESQUIOLEATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
PHENYL TRIMETHICONE
DISTEARYLDIMONIUM CHLORIDE
TRIETHOXYCAPRYLYLSILANE
TRIETHYLHEXANOIN
PHENOXYETHANOL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
CHRYSIN
HYDROGEN DIMETHICONE (20 CST)
DIMETHICONE
GLYCERIN
DICAPRYLYL CARBONATE
PANTHENOL
GALANTHUS NIVALIS SEED
GLYCERYL CAPRYLATE
DISTEARYLDIMONIUM
ETHYLHEXYLGLYCERIN
DIPHENYLSILOXY PHENYL TRIMETHICONE
MICA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53208-604-01 1 CONTAINER in 1 CARTON contains a CONTAINER
1 50 g in 1 CONTAINER This package is contained within the CARTON (53208-604-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2017
Labeler — LG Household and Health Care Inc (688276187)
Establishment
Name Address ID/FEI Operations
LG Household and Health Care Inc 688276187 manufacture (53208-604)
Establishment
Name Address ID/FEI Operations
ZENISCE Co.Ltd. 690188305 manufacture (53208-604)

Revised: 06/2017 LG Household and Health Care Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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