ALL AROUND SAFE BLOCK AQUA SUN GEL octinoxate octocrylene octisalate avobenzone

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate 7%, Octocrylene 5%, Octisalate 4.5%, Avobenzone 3%
Available from:
Able C&C Co., Ltd.
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

ALL AROUND SAFE BLOCK AQUA SUN GEL- octinoxate, octocrylene, octisalate,

avobenzone gel

Able C&C 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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MISSHA All Around Safe Block Aqua Sun Gel

ACTIVE INGREDIENTS

Octinoxate 7%

Octocrylene 5%

Octisalate 4.5%

Avobenzone 3%

PURPOSE

Sunscreen

Us es

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

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.

Wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: Ask a doctor

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

Directions

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water-resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin

againg. To decrease this risk, regularly use a sunscreen with SPF value of 15 or higher and other sun

protection measures including:

limit time in the sun, especially from 10a.m.-2p.m.

wear long-sleeved shirts, pants, hats and sunglasses

Other Information

protect the product in this container from excessive heat and direct sun

Inactive Ingredient

Water, Alcohol Denat., Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Bis-

Ethylhexyloxyphenol Methoxyphenyl Triazine

Questions of comments?

Visit www.misshaus.com or call 1-888-985-9887(Ext 104)

MISSHA ALL AROUND SAFE BLOCK AQUA SUN GEL SPF50+/PA+++

ALL AROUND SAFE BLOCK AQUA SUN GEL

Able C&C Co., Ltd.

octinoxate, octocrylene, octisalate, avobenzone gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:13733-234

Route of Administration

CUTANEOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

5 mg in 1 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7 mg in 1 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

4.5 mg in 1 g

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

3 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

1,1'-O XYBIS( 2 -PRO PANO L) (UNII: D5SV0 8 9 8 5Z)

BEMO TRIZINO L (UNII: PWZ1720 CBH)

METHYL METHACRYLATE (UNII: 19 6 OC776 8 8 )

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:13733-234-0 1

50 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 17

Labeler -

Able C&C Co., Ltd. (689540284)

Registrant -

Able C&C Co., Ltd. (689540284)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smecca Ko rea Co ., Ltd.

6 8 8 8 30 8 27

ma nufa c ture (13733-234)

Revised: 4/2017

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