FDA.reportPublic FDA data

Cay Skin Isle Glow Body SPF 45

Product NDC
82657-003
11-digit product format
826570003
Labeler code
82657
Product ID
82657-003_2889eedb-0de1-204f-e063-6394a90aaa96
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Cay Skin, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-29
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
30; 50; 100 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cay Skin Isle Glow Body SPF 45
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
db5f6bad-65ae-2b05-e053-2a95a90a8569Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82657-003-01Cay Skin Isle Glow Body SPF 45100 mL in 1 BOTTLE, PUMPLOTION1002
82657-003-01Cay Skin Isle Glow Body SPF 451 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82657-003CAY SKIN ISLE GLOW BODY SPF 45 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [CAY SKIN, INC.]2Current NDC, Legacy NDC, 2 package rows20241208_db5f6bad-65ae-2b05-e053-2a95a90a8569.zip

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 75 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorfb9cfd4f-a558-4df2-bbbf-b814ae19a1352026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9ddcda6-3d87-4197-a2c2-5b30016d32eb2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior25abef37-1726-491f-8a11-ac1a96378ed12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb0e315b3-a322-4607-b212-bcadd5aa99bc2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcc0f19fc-7b6f-4454-9a77-dc11f0fd12512026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 10N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc361a514-5fc9-42a7-b1fc-28e4a11ad7332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00 NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diordb38ced5-dfbe-4b7e-b4ae-3065df1898b02026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4ead1ce8-f31d-4676-8619-8d49dd62db2e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior827caf09-222e-487a-941c-44eb5c13d5d62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf3c378e1-853b-463e-9fc3-6a54ef8610442026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc3a479c4-807e-4c52-a27f-eea8705b9c1e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcb63faaa-82d8-469a-a9a1-88b09e02cc352026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc20b0b8b-366a-47ff-84b6-264fa8ed6de02026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior31d89246-418d-4ed4-8e32-7aa2422073a92026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior31b74e11-c5e5-4086-baa5-e7a39dc556a02026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior29ec217b-7726-4590-8a0d-e4b08217e2222026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorceabea37-020c-49e0-a049-3100ed46ff572026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior915a0b1f-b26e-4fea-95f3-ccec2bcab3892026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9a313d8e-003d-4d40-b892-0f2270e4f6c22026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf560de93-4099-4ad9-8eb6-fe2a52ac82a12026-01-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82657-003-01826570003011 BOTTLE, PUMP in 1 CARTON (82657-003-01) / 100 mL in 1 BOTTLE, PUMP2022-03-290000-00-00NoNoCurrent