UV Defense Sun Block Tissues (BROAD SPECTRUM, SPF30) by C&TECH CORPORATION

UV Defense Sun Block Tissues (BROAD SPECTRUM, SPF30) by

Drug Labeling and Warnings

UV Defense Sun Block Tissues (BROAD SPECTRUM, SPF30) by is a Otc medication manufactured, distributed, or labeled by C&TECH CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UV DEFENSE SUN BLOCK TISSUES (BROAD SPECTRUM, SPF30)- octocrylene liquid 
C&TECH CORPORATION

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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octocrylene, homosalate, ethylhexyl salicylate (OCTISALATE), butyl methoxydibenzoylmethane (AVOBENZONE)

methylpropanediol, alcohol denat., undecane, tridecane, glycine, serine, etc.

sun protect

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Keep out of reach of children.

1. Rub the surface of the pouch evenly before use to avoid the content from settling down.

2. Lift the front seal and pull out one sheet. Spread evenly over face, neck and arm which are most likely to get sun damage.

3. Make sure to reseal the pouch after each use.

for external use only

UV DEFENSE SUN BLOCK TISSUES (BROAD SPECTRUM, SPF30) 
octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71621-0012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIDECANE (UNII: A3LZF0L939)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71621-0012-1	100 g in 1 POUCH; Type 0: Not a Combination Product	03/01/2018	12/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2018	12/06/2019

Labeler - C&TECH CORPORATION (688204698)

Registrant - C&TECH CORPORATION (688204698)

Establishment
Name	Address	ID/FEI	Business Operations
C&TECH CORPORATION		688204698	manufacture(71621-0012)

Revised: 12/2019

Document Id: 99037a7d-0f65-74ea-e053-2a95a90a3621

34390-5

Set id: 6856a354-e851-10cc-e053-2a91aa0a5e70

Version: 2

Effective Time: 20191206

 

C&TECH CORPORATION