AC CARE BEES SUN PROTECTION BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide cream 
DongSung Pharm Co., Ltd.

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.

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42361-152 Drug Facts

Drug Facts

Ensulizole 3.9%

Octinoxate 7.4%

Octocrylene 3.0%

Titanium Dioxide 4.9%

Zinc Oxide 4.9%

Drug Facts

Sunscreen

Uses

Not only will it help prevent sunburn, it also reduces the risk of skin cancer and early skin aging if used as directed with other sun protection measures. (SPF value of 15 or higher)

Warnings

For external use only. Do not use on damaged or broken skin. Discontinue use if signs of irritation or rash appear. Avoid contact with eyes. Wash off immediately with cold water if product comes in contact with eyes. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away. 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. and wear long-sleeved shirts, pants, hats and sunglasses. For use on skin only.

Warnings

Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Directions

At the end of basic skin care regimen, apply liberally on face to cover the entire facial area and lightly go over parts where extra cover-up is needed with detailed perfection. Apply 15 minutes before sun exposure. For added protection, reapply at least every 2 hours, after swimming, towel drying or extended sun exposure. Use a water resistant sunscreen if swimming or sweating. Children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Cocoglycerides, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Glycerin, Cetearyl Alcohol, Triethanolamine, Dimethicone, Butylene Glycol, Pentaerythrityl Distearate, Disodium Cetearyl Sulfosuccinate, Beheneth-25, Aluminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Phenoxyethanol, Magnesium Aluminum Silicate, Fragrance, Xanthan Gum, Triethoxycaprylsilane

Sun Protection

Broad Spectrum SPF 50+

UVA/UVB Protection

Mild and Lightweight Essential Sunscreen For Face

package image

AC CARE BEES SUN PROTECTION  BROAD SPECTRUM SPF 50
ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42361-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE39 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE49 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION49 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
TROLAMINE (UNII: 9O3K93S3TK)  
COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BEHENETH-25 (UNII: 0G17KJ5M7P)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42361-152-011 in 1 CARTON01/16/201706/28/2021
170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/16/201706/28/2021
Labeler - DongSung Pharm Co., Ltd. (687856557)
Registrant - Dong Sung World Wide USA, Inc. (784969219)
Establishment
NameAddressID/FEIBusiness Operations
Omar Sharif Cosmetic Co., Ltd.689316318manufacture(42361-152)

Revised: 6/2021
 
DongSung Pharm Co., Ltd.