FDA.reportPublic FDA data

Leg Body Makeup

Product NDC
68577-121
11-digit product format
685770121
Labeler code
68577
Product ID
68577-121_2a253b4b-19eb-3b9d-e063-6294a90ae105
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
0752753e-cac9-9166-e063-6394a90a4d8dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4ee46d8-7228-4160-88ad-868cc5abf72fProduct name520260223
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-121-01Leg Body Makeup100 mg in 1 TUBECREAM1002
68577-121-01Leg Body Makeup1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-121LEG BODY MAKEUP (OCTISALATE, OCTOCRYLENE) CREAM [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0752753e-cac9-9166-e063-6394a90a4d8d.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 185 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum Daily BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15da0cb1-e695-cec3-e063-6394a90a1afa2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Face Liquid Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15daac41-54b6-096d-e063-6294a90a07362025-09-23WarningsExact identifier
application number: M020
Mtn. Bum by Sun Bum and Mcfetridge Mineral Sunscreen Face Stick SPF 50ZINC OXIDESun Bum, LLC3f8101b1-297d-2ad8-e063-6294a90a9cff2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Glow Tinted Sunscreen Moisturizer Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESun Bum, LLC20c48752-3ad9-5993-e063-6294a90ae1b02025-09-23WarningsExact identifier
application number: M020
CVS SPF 60 Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS26d1b568-ad9c-80d7-e063-6394a90a2cbf2025-09-21WarningsExact identifier
application number: M020
Radiant Shield Tinted Mineral Sunscreen SPF 40ZINC OXIDECosMedical Technologies, LLCf229b928-49fd-4e02-99c1-b2cd9166894f2025-09-19WarningsExact identifier
application number: M020
EquateDaytimeFaceLotionEQUATE DAYTIME FACE LOTION WITH SUNSCREEN, SPF 30, 3 OZWalmart Inc.2efc7087-f4ad-2f2e-e063-6394a90a13022025-09-18WarningsExact identifier
application number: M020
ERBORIAN CC RED CORRECTERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAMKolmask Co., Ld.09ca2d4b-e0c2-9961-e063-6394a90aa82e2025-09-18Exact identifier
application number: M020
ELROEL Pang Pang Sun Cushion PlusZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.5ffaad65-f0b2-416a-b0a3-b92e880641e42025-09-18WarningsExact identifier
application number: M020
e.l.f. Camo CC Cream SPF 30 Fair 125 CHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEe.l.f. Cosmetics, Inc.407f9c0d-31c6-f5bb-e063-6394a90a4db42025-09-18WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC1630feee-7e0d-c6f4-e063-6294a90a7b1c2025-09-17WarningsExact identifier
application number: M020
Guise Tinted DropsZINC OXIDEDonis Men LLC3f039049-5004-2888-e063-6294a90a51502025-09-17WarningsExact identifier
application number: M020
ONE SIZE ON TIL DAWNONE SIZE ON TIL DAWNPogi Beauty LLC3f05d90b-9274-4d21-e063-6294a90a84852025-09-17WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint DP3ZINC OXIDEPUR Minerals3f073413-b314-e5da-e063-6394a90a9ab42025-09-17WarningsExact identifier
application number: M020
e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 WHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEe.l.f. Cosmetics, Inc.3fa7ef54-2c4d-9883-e063-6294a90a8d882025-09-17WarningsExact identifier
application number: M020
CVS SPF 50 Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECVS26a69a47-947a-a478-e063-6394a90aa4682025-09-16WarningsExact identifier
application number: M020
SkinSuit TM 3 in 1 Moisturizer SPF 50ZINC OXIDESkin Authority LLC5eb27be9-9e80-4f4a-b193-b918d831555d2025-09-15WarningsExact identifier
application number: M020
Sun and Honey Tallow Sunscreen SPF 30ZINC OXIDEAmara Ventures3eda8a70-7c9e-e920-e063-6394a90a85a22025-09-15WarningsExact identifier
application number: M020
Klein Tools Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKLEIN TOOLS, INC.3edcc26a-d960-3fa8-e063-6394a90ab7032025-09-15WarningsExact identifier
application number: M020
Klein Tools Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEKLEIN TOOLS, INC.3ede5e54-4c9f-02f7-e063-6294a90a9df62025-09-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-121-01685770121011 TUBE in 1 CARTON (68577-121-01) / 100 mg in 1 TUBE1 tube2023-06-01NoNoCurrent