UV Capture Vita Capsule Sun Gel

Drug Labeling and Warnings

Drug Details [pdf]

UV CAPTURE VITA SUN GEL- ethylhexyl methoxycinnamate, ethylhexy salicate, butyl methoxydibezoylmethane gel 
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 Vita Capsule Sun Gel

ACTIVE INGREDIENT

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Ethylhexyl Methoxycinnamate 7%: Sunscreen
• Ethylhexyl Salicylate 4.5%: Sunscreen
• Butyl Methoxydibenzoymethane 3 %: 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

WATER
BUTYLENE GLYCOL
GLYCERIN
DOCOSANOL
NEOPENTYL GLYCOL DIHEPTANOATE
DICAPRYLYL CARBONATE
PENTYLENE GLYCOL
BENZOTRIAZOLYL DODECYL P-CRESOL
CAPRYLYL GLYCOL
ARGININE
CARBOMER 934
GELLAN GUM (LOW ACYL)
XANTHAN GUM
MELIA AZEDERACH WHOLE
MAGNESIUM DISODIUM EDTA
MELIA AZEDERACH LEAF
CURCUMA LONGA WHOLE
LAWSONIA INERMIS WHOLE
OCIMUM GRATISSIMUM LEAF OIL
NIACINAMIDE
PANTHENOL
HIPPOPHAE RHAMNOIDES FRUIT JUICE
CORALLINA OFFICINALIS
ASCORBYL TETRAISOPALMITATE
CENTELLA ASIATICA
PORTULACA OLERACEA WHOLE
GLYCERYL LINOLEATE
GLYCERYL LINOLENATE
VITEX AGNUS-CASTUS WHOLE
MATRICARIA RECUTITA FLOWERING TOP
TOCOPHEROL
PHENOXYETHANOL
PRUNUS MUME FRUIT
ALOE ARBORESCENS LEAF
ETHYLHEXYLGLYCERIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV CAPTURE VITA SUN GEL 
ethylhexyl methoxycinnamate, ethylhexy salicate, butyl methoxydibezoylmethane gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 mL
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13) (2-ETHYLHEXYL BENZOATE - UNII:R63ZWW1A13)	2-ETHYLHEXYL BENZOATE	2.25 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.50 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ARGININE (UNII: 94ZLA3W45F)
XANTHAN GUM (UNII: TTV12P4NEE)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-061-02	1 in 1 CARTON	07/01/2014	12/01/2018
1	NDC: 58930-061-01	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
Cosmax, Inc.		689049693	manufacture(58930-061)

Revised: 6/2019

Document Id: 87093467-b1a1-4b34-9d04-fa581a4c9a2c

34390-5

Set id: 5e19b8d6-2b12-43f2-87dd-2a536009113b

Version: 4

Effective Time: 20190612