FDA.reportPublic FDA data

QC SPF 30 Sunscreen Lotion

Manufacturer
CDMA | Derma Care Research Labs, LLC | Derma Care Research Labs
Effective date
2024-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:48

Label at a glance#

ProductQC SPF 30 Sunscreen
Active ingredientAVOBENZONE, OCTOCRYLENE, HOMOSALATE, OCTISALATE
Label structure8 sections

Indications and 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.

Dosage and administration

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, especial...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, stearic acid, dimethicone, tocopherol, carbomer, disodium EDTA, ethylhexylglycerin, phenoxyethanol, polyglyceryl-3 methylglucose distearate, sorbitan isostearate, benzyl alcohol, triethanolamine, fragrance.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-913-08QC SPF 30 Sunscreen227 g in 1 BOTTLE, PLASTICLOTION2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-913QC SPF 30 SUNSCREEN (AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%) LOTION [CDMA]2Current NDC, 1 package rows20241217_f80ceb05-0bd4-1355-e053-6294a90afb19.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-91363868-913-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
EICOSYL POVIDONEXQQ9MKE2BJIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
TOCOPHEROLR0ZB2556P8IACT
BENZYL ALCOHOLLKG8494WBHIACT
HOMOSALATEV06SV4M95SACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATEW19EIO0DBEIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SORBITOL506T60A25RIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM7FLD91C86KIACT
OCTISALATE4X49Y0596WACTIB
DIMETHICONE 3502Y53S6ATLUIACT
CARBOMER 9404Q93RCW27EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QC SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%CDMAf80ceb05-0bd4-1355-e053-6294a90afb192024-12-15WarningsExact identifier
ndc (package): 63868-913-08
ndc (product): 63868-913
ndc11 (package): 63868091308
spl id: 2957af4d-11df-3abe-e063-6394a90a2eff
spl set id: f80ceb05-0bd4-1355-e053-6294a90afb19

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.