FDA.reportPublic FDA data

SLMD

Product NDC
73318-7008
11-digit product format
733187008
Labeler code
73318
Product ID
73318-7008_4736dd1e-b4a0-ddb9-e063-6394a90a9743
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octisalate, Oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Skin PS Brands
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-11
Substance
OCTISALATE; OXYBENZONE; AVOBENZONE; OCTINOXATE
Active strength
1.5; 3.5; 2.5; 7.5 mg/g; mg/g; mg/g; mg/g
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
SLMD
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE1.5 mg/g
OXYBENZONE3.5 mg/g
AVOBENZONE2.5 mg/g
OCTINOXATE7.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1aa36c01-21b5-f06e-e063-6294a90a608fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73318-7008-2SLMD60 g in 1 TUBECREAM603
73318-7008-2SLMD1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73318-7008SLMD (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [SKIN PS BRANDS]2Current NDC, 2 package rows20241228_1aa36c01-21b5-f06e-e063-6294a90a608f.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 55 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EWC Slow Lightweight Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEEWC Ventures, LLC063426b8-d1cf-4ee2-8ab8-ff007227eab82026-03-10WarningsExact identifier
application number: M020
Olay Vitamin C Brightening Facial Moisturizer with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4cb268ea-f2b5-ddd1-e063-6394a90a1e962026-03-10WarningsExact identifier
application number: M020
Vacation Grand Cuvee Shimmer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.e0b3d90b-ba56-43e5-aa68-8e5f473628ff2026-03-09WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique ANTHELIOS UVPRO SPORT INVISIBLE SUNSCREEN BROAD SPECTRUM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA, Inc.77f46325-600c-40ff-94fc-ea82d43134c22026-03-09WarningsExact identifier
application number: M020
Civant 50 Sunscreen Broad Spectrum SPF 50OCTOCRYLENE, ZINC OXIDECivant LLCe23622b8-49dd-45b9-8c51-1a83181cc7bd2026-03-09WarningsExact identifier
application number: M020
HydroScreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMETHODIQ INC.4c9d5dfd-d790-fffc-e063-6294a90a4d302026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 45 SunscreenZINC OXIDEShimoda Prime Products, LLC3d48e3e2-18c7-e004-e063-6294a90af4f22026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 30 SunscreenZINC OXIDEShimoda Prime Products, LLC68df620b-7c1c-448c-93fd-91459e393c642026-03-09WarningsExact identifier
application number: M020
EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEADEM, Inc.4ca05e2f-f0c5-821c-e063-6294a90a90b82026-03-09WarningsExact identifier
application number: M020
COOLA SunBlur Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c6439e8-abda-663a-e063-6394a90ac43b2026-03-06WarningsExact identifier
application number: M020
COOLA SunBlur Makeup Mist SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c666a82-293e-06df-e063-6294a90ad5512026-03-06WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4d6d1fda-da78-62ed-e063-6294a90ac1052026-03-06WarningsExact identifier
application number: M020
Palio Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESole Palio LLC071d5113-8fe8-44bb-8322-542eafc2800a2026-03-05WarningsExact identifier
application number: M020
Olay Age Defying Classic Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company4c49dbf1-d1fe-ad4a-e063-6394a90af1512026-03-05WarningsExact identifier
application number: M020
SPF 70 Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aadc378-dc34-9a37-e063-6294a90ad49e2026-03-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.14b9ec0e-6fff-44b1-e063-6394a90aab972026-03-05WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.4c35fbbc-a79d-318f-e063-6394a90a30a72026-03-04WarningsExact identifier
application number: M020
Kids Mineral Sunscreen Stick SPF 50ZINC OXIDESmalls Brand LLC DBA Roe Wellness4c37855b-08c0-0aa7-e063-6394a90a88422026-03-04WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Incbe03b588-afbd-41d1-be96-444d735c97682026-03-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73318-7008-2733187008021 TUBE in 1 CARTON (73318-7008-2) / 60 g in 1 TUBE1 tube2024-06-11NoNoCurrent