SUN BLOCK - octyl methoxycinnamate benzophenone-3 titanium dioxide homosalate cream
Yuyao Jessie Promotional Products 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 DRUG FACT

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:51414-200
Route of Administration	TOPICAL

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

#	Item Code	Package Description
Packaging
1	NDC:51414-200-01	15 mL in 1 BOTTLE
2	NDC:51414-200-02	20 mL in 1 BOTTLE
3	NDC:51414-200-03	30 mL in 1 BOTTLE
4	NDC:51414-200-04	40 mL in 1 BOTTLE
5	NDC:51414-200-05	50 mL in 1 BOTTLE
6	NDC:51414-200-06	60 mL in 1 BOTTLE
7	NDC:51414-200-07	70 mL in 1 BOTTLE
8	NDC:51414-200-08	80 mL in 1 BOTTLE
9	NDC:51414-200-09	90 mL in 1 BOTTLE
10	NDC:51414-200-10	100 mL in 1 BOTTLE
11	NDC:51414-200-11	200 mL in 1 BOTTLE
12	NDC:51414-200-12	250 mL in 1 BOTTLE
13	NDC:51414-200-13	300 mL in 1 BOTTLE
14	NDC:51414-200-14	400 mL in 1 BOTTLE
15	NDC:51414-200-15	500 mL in 1 BOTTLE

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 Promotional Products Co., Ltd. (529892305)

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Promotional Products Co., Ltd.		529892305	manufacture