Active Ingredients

Active ingredients Purpose

Homosalate..................................Sunscreen

Octyl methoxycinnamate..............Sunscreen

Benzophenone-3..........................Sunscreen

Titanium dioxide...........................Sunscreen

Purpose

Active ingredients Purpose

Homosalate..................................Sunscreen

Octyl methoxycinnamate..............Sunscreen

Benzophenone-3..........................Sunscreen

Titanium dioxide...........................Sunscreen

Uses

Helps prevent sunburn
Higher SPF gives more protection
For skin highly sensitive to sunburn

For external use only

When using this product

Keep out eyes. Rinse with water to remove

Stop use and ask a doctor if rash or irritation develops and lasts

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

if swallowed, contact a poison control center or doctor right away

Directions

Apply liberally before sun exposure and as needed
Children under 6 months of age: ask a doctor

Inactive ingredients

Water, Cetearyl Alcohol, Glycerin monosteareate Gctt, Propylparaben, Methylparaben, glycerol, EDTA-2NA, Vinylchloride-methylacrylate, copolymer, Methylisothiazolinone

Other Information

Store at room temperature

Principal Display Panel

label

SUNSCREEN CREAM SPF 30
homosalate, octyl methoxycinnamate, benzophenone-3, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70897-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
EDETIC ACID (UNII: 9G34HU7RV0)
VINYL CHLORIDE (UNII: WD06X94M2D)
GLATIRAMER ACETATE (UNII: 5M691HL4BO)
DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70897-008-01	6 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2019

Labeler - Davemed Healthcare Co., Ltd (529128716)

Name	Address	ID/FEI	Business Operations
Establishment
Davemed Healthcare Co., Ltd		529128716	manufacture(70897-008)

Sunscreen Cream SPF 30