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

Sunscreen Cream SPF 30 by

Drug Labeling and Warnings

Sunscreen Cream SPF 30 by is a Otc medication manufactured, distributed, or labeled by Davemed Healthcare Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Uses

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

WARNINGS

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

Other Information

Store at room temperature

Principal Display Panel

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Davemed Healthcare Co., Ltd (529128716)

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