DEARDERM DAILY MOSITURE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

DEARDERM DAILY MOSITURE SUNSCREEN by

Drug Labeling and Warnings

DEARDERM DAILY MOSITURE SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by RAINBOW BEAUTY COMPANY, Samson Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Homosalate 15%, Oxybenzone 6%, Octisalate 5% Avobenzone 3%,t Octocrylene 2.4%

Purpose

Sunscreen

Use

helps prevent sunburn.

Warnings

• For external use only

When using this product

• Do not get it into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if Irritation or rash develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply generous amount evenly to all areas 15 minutes before sun exposure
• Reapply at frequent intervals and after swimming or towel drying
• Ask a doctor before use on infants under six months of age

Other Information

• May Stain some materials

Inactive Ingredients

Water (Aqua), Stearyl Alcohol, Cetyl Alcohol, Glyceryl Stearate (and) Peg-100 Stearate, Ethylhexyl Palmitate, Dimethicone, Paraffinum Liquidum, Phenoxyethanol, Aloe Barbadensis Leaf Juice, PVP, Menthone Glycerin Acetal, Triethanolamine, Carbomer, Fragrance, PEG-8, Disodium EDTA, Ethylhexylglycerin, Tocopheryl Acetate, Retinyl Palmitate.

SPL UNCLASSIFIED SECTION

Distributed by
Rainbow Beauty Company

Manufactured by
Samson Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Daily Moist
Sunscreen
For Family

DEARDERM

SPF
50+
PA+++

BROAD SPECTRUM
UVA/UVB Protection

ALOE VERA & VITAMIN B

Reduces the Appearance of Photo-Aging

88 mL / 3 fl oz

INGREDIENTS AND APPEARANCE

DEARDERM DAILY MOSITURE SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72279-078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	150 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	24 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72279-078-01	88 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2018

Labeler - RAINBOW BEAUTY COMPANY (012749151)

Establishment
Name	Address	ID/FEI	Business Operations
Samson Pharmaceuticals Inc.		088169581	MANUFACTURE(72279-078)