SPF 30 Sunscreen by Derma Care Research Labs, LLC

Drug Details [pdf]

SPF 30 SUNSCREEN- avobenzone 3%, octisalate 5%, octocrylene 8% spray
Derma Care Research Labs, LLC

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.

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Active Ingredients

Avobenzone 3%, Octisalate 5%, Octocrylene 8%

Purpose

Sunscreen

Uses

Helps prevent sunburn
if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only. Flammable: do not use while smoking or near heat or flame.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 degrees F.

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

limit time in the sun, especially from 10 am to 2 pm
wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months: ask a doctor.

Hold container 4 to 6 inches from the skin to apply. Do not spray directly into face. Spray on hands then apply to face. Do no apply in windy conditions. Use in a well-ventilated area.

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Cannabidiol, Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin, Stearoxytrimethysilane, Tocopherol.

Label

Label Label Label

SPF 30 SUNSCREEN
avobenzone 3%, octisalate 5%, octocrylene 8% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-523
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
TOCOPHEROL (UNII: R0ZB2556P8)
CANNABIDIOL (UNII: 19GBJ60SN5)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72839-523-03	85 g in 1 CAN; Type 0: Not a Combination Product	03/31/2020
2	NDC: 72839-523-06	170 g in 1 CAN; Type 0: Not a Combination Product	03/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/31/2020	12/16/2021

Labeler - Derma Care Research Labs, LLC (116817470)

Revised: 12/2021

Document Id: d348fe9c-5c29-0f93-e053-2a95a90a015b

Set id: acb47ec8-d09c-56c8-e053-2a95a90a7e77

Version: 2

Effective Time: 20211216