UV Capture Sun Pact No.21

Drug Labeling and Warnings

Drug Details [pdf]

UV CAPTURE SUN PACT- titnium dioxide, ethylhexyl methoxycinnamate, octocrylene powder 
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.

----------

UV Capture Sun Pact No.21

ACTIVE INGREDIENT

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Titanium Dioxide 7.9%: Sunscreen
• Ethylhexyl Methoxycinnamate 3.0%: Sunscreen
• Octocrylene 0.9%: 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

TALC
MICA
SILICA DIMETHYL SILYLATE
NYLON-12
BARIUM SULFATE
DIETHYLHEXYL SUCCINATE
METHYL METHACRYLATE
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER
AVOBENZONE
METHICONE (20 CST)
TRIETHOXYCAPRYLYLSILANE
BROWN IRON OXIDE
1,2-HEXANEDIOL
HYDROGENATED SOYBEAN LECITHIN
GLYCERYL CAPRYLATE
ALUMINUM OXIDE
MAGNESIUM MYRISTATE
WATER
CAMELLIA SINENSIS WHOLE
ALLANTOIN
BAMBUSA VULGARIS SAP
ADANSONIA DIGITATA WHOLE
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW)
PUNICA GRANATUM WHOLE
RUBUS IDAEUS FRUIT VOLATILE OIL
HYALURONATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
TREHALOSE
BUTYLENE GLYCOL
CENTELLA ASIATICA
PLATYCODON GRANDIFLORUM ROOT
POLYGALA TENUIFOLIA ROOT
BRASSICA OLERACEA VAR. ITALICA WHOLE
CAMELLIA JAPONICA LEAF
ERUCA VESICARIA SUBSP. SATIVA LEAF
GINKGO BILOBA LEAF OIL
MEDICAGO SATIVA LEAF
TRITICUM POLONICUM SEED
DIOSPYROS KAKI LEAF
MENTHA ARVENSIS LEAF

AMINOPROPYL DIMETHICONE

FRAGRANCE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV CAPTURE SUN PACT 
titnium dioxide, ethylhexyl methoxycinnamate, octocrylene powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.80 g  in 10 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.30 g  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.09 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
AVOBENZONE (UNII: G63QQF2NOX)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-064-02	1 in 1 CARTON	07/01/2014	12/01/2018
1	NDC: 58930-064-01	10 g in 1 CASE; 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(58930-064)

Revised: 6/2019

Document Id: 24e0d20d-4d7c-436b-9591-f80c32aeec7d

34390-5

Set id: f4cb1d63-aad7-4bd0-b78a-b9b2bbc1b98e

Version: 4

Effective Time: 20190611