SUN BLOCK- octyl methoxycinnamate benzophenone-3 titanium dioxide homosalate cream

Sun Block by

Drug Labeling and Warnings

Sun Block by is a Otc medication manufactured, distributed, or labeled by Yuyao Jessie Commodity Co.,Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/30/2010

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

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