UV Capture Sebum Control Sun Cream

Drug Labeling and Warnings

Drug Details [pdf]

UV CAPTURE SEBUM CONTROL SUN CREAM- ethylhexyl methoxycinnamate, zinc oxide, ethylhexy salicate, titanuim dioxide, bis-ethylhexyloxyphenol methoxyphenyl triazine cream 
Carver Korea 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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UV Capture Sebum Control Sun Cream

Drug Facts

• Active Ingredients: Purpose
• Ethylhexyl Methoxycinnamate 6.8%: Sunscreen
• Zinc Oxide 5.1%: Sunscreen
• Ethylhexyl Salicylate 4.5%: Sunscreen
• Titanium Dioxide 4.3%: Sunscreen
• Bis-Ethylhexiloxyphenol Methoxyphenol Triazine 0.5%: 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

Warning

For external use only

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 product is swallowed, get medical help or contact a Poison Control Center right away.

- For sunscreen use:

- apply liberally 15 minutes before sun exposure 

- apply reapply at least every 2 hours Sun Protection Measures.

- children under 6 months: Ask a doctor

Dosage: Small Amount

Administration: apply to a clean skin and massage gently

INACTIVE INGREDIENT

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV CAPTURE SEBUM CONTROL SUN CREAM 
ethylhexyl methoxycinnamate, zinc oxide, ethylhexy salicate, titanuim dioxide, bis-ethylhexyloxyphenol methoxyphenyl triazine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.4 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.5 g  in 50 mL
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13) (2-ETHYLHEXYL BENZOATE - UNII:R63ZWW1A13)	2-ETHYLHEXYL BENZOATE	2.25 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.15 g  in 50 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-060-02	1 in 1 CARTON	07/01/2014	12/01/2018
1	NDC: 58930-060-01	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 not final	part352	07/01/2014	12/01/2018

Labeler - Carver Korea Co.,Ltd (688442290)

Registrant - Jemian USA Inc. (078822273)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		688732723	manufacture(58930-060)

Revised: 6/2019

Document Id: b8e075e4-b86c-402e-b100-73deca211896

34390-5

Set id: a66338f2-c055-4c58-9c2e-7a175753e0f6

Version: 3

Effective Time: 20190611