OTC Medication Information: IM DERMA RELIEF SUNSTICK

IM DERMA RELIEF SUNSTICK- octinoxate, octocrylene and octisalate stick
Normalest 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.

relief
(click image for full-size original)

IM DERMA RELIEF SUNSTICK
octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72284-0010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.05 g in 15 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 1.2 g in 15 g
OCTISALATE (OCTISALATE) OCTISALATE 0.675 g in 15 g
Inactive Ingredients
Ingredient Name Strength
HYALURONIC ACID
CENTELLA ASIATICA
DIMETHICONE
PARAFFIN
TRIETHYLHEXANOIN
SILICON DIOXIDE
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE
PHENYL TRIMETHICONE
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
MICROCRYSTALLINE WAX
CANDELILLA WAX
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
BEMOTRIZINOL
DIPROPYLENE GLYCOL
GLYCERIN
WATER
1,2-HEXANEDIOL
SORBITAN SESQUIOLEATE
HYDROGENATED SOYBEAN LECITHIN
POLYGLYCERYL-10 OLEATE
GLYCYRRHIZA GLABRA
ADENOSINE
MADECASSOSIDE
PENTYLENE GLYCOL
BUTYLENE GLYCOL
ALOE VERA LEAF
HYALURONATE SODIUM
Product Characteristics
Color Score
Shape ROUND Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72284-0010-1 1 CONTAINER in 1 BOX contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the BOX (72284-0010-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/05/2019
Labeler — Normalest Co., Ltd. (694812877)
Registrant — Normalest Co., Ltd. (694812877)
Establishment
Name Address ID/FEI Operations
Normalest Co., Ltd. 694812877 manufacture (72284-0010)

Revised: 12/2019 Normalest Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.