FDA.reportPublic FDA data

Leg Body Makeup

Product NDC
68577-110
11-digit product format
685770110
Labeler code
68577
Product ID
68577-110_2a250b2c-5b7a-43a4-e063-6294a90ac1b7
Type
HUMAN OTC DRUG
Nonproprietary name
Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
Substance
OCTOCRYLENE; OCTISALATE
Active strength
6; 3.2 mg/100mg; mg/100mg
NDC exclude flag
No
Listing certified through
2026-12-31
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
Leg Body Makeup
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE6 mg/100mg
OCTISALATE3.2 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
06ab109e-abcf-0861-e063-6394a90a9375Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4ee46d8-7228-4160-88ad-868cc5abf72fProduct name520260223
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-110-01Leg Body Makeup100 mg in 1 TUBECREAM1003
68577-110-01Leg Body Makeup1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-110LEG BODY MAKEUP (OCTISALATE, OCTOCRYLENE) CREAM [COSMAX USA, CORPORATION]3Current NDC, 2 package rows20241228_06ab109e-abcf-0861-e063-6394a90a9375.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 267 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf5a006d1-e957-4063-9b45-2874a1445a332024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6943a531-c4e7-4e98-9970-3a30b9681b7b2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora74102d3-b535-4419-8e21-e961980e489d2024-11-11WarningsExact identifier
application number: M020
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50TITANIUM DIOXIDE AND ZINC OXIDEDARPHIN DIST.91277514-4db0-4b40-b95a-3530cac711df2024-11-11WarningsExact identifier
application number: M020
DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAveda Corporationdfa84bcc-a9b4-426d-8733-35f58c40e94d2024-11-11WarningsExact identifier
application number: M020
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYfef47045-1d3c-4f08-acec-e96abefbc2612024-11-08WarningsExact identifier
application number: M020
MeleNO SHADE SUNSCREEN OILCONOPCO Inc. d/b/a Unileverbd969eab-1da6-76a8-e053-2995a90a5c472024-11-07WarningsExact identifier
application number: M020
Vaseline Men plus Care Hydrate FaceAGING CHEST AND NECK RESCUE TREATMENT CREAMCONOPCO Inc. d/b/a Unileverbd0a9f3c-eaa9-47d0-e053-2995a90ab6172024-11-07WarningsExact identifier
application number: M020
VaselineAGING CHEST AND NECK RESCUE TREATMENT CREAMCONOPCO Inc. d/b/a Unileverbd965bbc-c9d1-c8da-e053-2995a90a22582024-11-07WarningsExact identifier
application number: M020
St. Ives Men plus Care Hydrate FaceSOLUTIONS CLEAR SKIN MOISTURIZER SUNSCREENCONOPCO Inc. d/b/a Unileverbcbaaa15-479d-b130-e053-2a95a90afa3b2024-11-07WarningsExact identifier
application number: M020
Dove Men plus Care Hydrate FaceAVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENECONOPCO Inc. d/b/a Unilever5c28d679-3f92-49e3-8bef-de1c3870f0092024-11-07WarningsExact identifier
application number: M020
Mele Men plus Care Hydrate FaceNO SHADE SUNSCREEN OILCONOPCO Inc. d/b/a Unileverbb2921bc-8892-1db2-e053-2995a90ae28c2024-11-07WarningsExact identifier
application number: M020
PondsREJUVENESS ANTI-WRINKLE DAILY MOISTURIZER WITH SUNSCREEN SPF 30CONOPCO Inc. d/b/a Unilever736ee790-99f7-686c-e053-2a91aa0ad16e2024-11-07WarningsExact identifier
application number: M020
Mele Men plus Care Hydrate FaceDEW THE MOST SHEER MOISTURIZER SUNSCREENCONOPCO Inc. d/b/a Unileverbb27185b-5732-a648-e053-2a95a90aa9302024-11-07WarningsExact identifier
application number: M020
PondsCLARANT B3 EVEN SKIN TONE DAILY MOISTURIZER WITH SUNSCREEN SPF 30CONOPCO Inc. d/b/a Unilever736ee790-9a15-686c-e053-2a91aa0ad16e2024-11-07WarningsExact identifier
application number: M020
Byoma Ultralight Face Fluid SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBYOMA LIMITED2657bca4-bdc7-d959-e063-6394a90a2aa12024-11-07WarningsExact identifier
application number: M020
Byoma Ultralight Face Fluid SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBYOMA LIMITED2658df86-8cbb-83dd-e063-6394a90ac4e82024-11-07WarningsExact identifier
application number: M020
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY547388c6-378b-488b-89d1-c77ebc5d2ed82024-11-07WarningsExact identifier
application number: M020
SPF30 SUMMER BLEND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY9641b71a-81f2-4157-801b-162188392a912024-11-07WarningsExact identifier
application number: M020
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd79cf2d9-4923-452a-bb44-67e059ee37ee2024-11-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-110-01685770110011 TUBE in 1 CARTON (68577-110-01) / 100 mg in 1 TUBE1 tube2023-06-01NoNoCurrent