SUN BLOCK- octyl methoxycinnamate benzophenone-3 titanium dioxide homosalate cream
Yuyao Jessie Commodity 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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Sunblock 200-201

Active Ingredient

OctylMethoxycinnamate,Benzophenone-3,Homosalate, Titanium dioxide

Use

Protection from the sun’s damaging effects

Warnings

For external use only

Not recommended for children under 6 months of age

Direction

Apply liberally and evenly before sun exposure.

Inactive Ingredient

Water,CetearylAlcohol,Glycerinmonostearate,

Gctt,Propylparaben,Methylparaben,

glycerol,EDTA-2NA,Vinylchloride-methylacrylate,

copolymer,Methylisothiazolinone

SUN BLOCK
octyl methoxycinnamate benzophenone-3 titanium dioxide homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51414-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	8 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	7.5 g in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETEARYL NONANOATE (UNII: F6ZWV2F361)
EDETIC ACID (UNII: 9G34HU7RV0)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
VINYL CHLORIDE (UNII: WD06X94M2D)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51414-201-01	15 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
2	NDC:51414-201-02	20 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
3	NDC:51414-201-03	30 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
4	NDC:51414-201-04	40 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
5	NDC:51414-201-05	50 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
6	NDC:51414-201-06	60 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
7	NDC:51414-201-07	70 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
8	NDC:51414-201-08	80 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
9	NDC:51414-201-09	90 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
10	NDC:51414-201-10	100 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
11	NDC:51414-201-11	200 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
12	NDC:51414-201-12	250 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
13	NDC:51414-201-13	300 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
14	NDC:51414-201-14	400 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018
15	NDC:51414-201-15	500 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/30/2010

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-201)

Revised: 1/2018

Document Id: 6259609f-862a-1472-e053-2991aa0a10a2

Set id: 6259609f-8629-1472-e053-2991aa0a10a2

Version: 1

Effective Time: 20180105

Yuyao Jessie Commodity Co.,Ltd.