FDA.reportPublic FDA data

I.C. Industrial Sunscreen

Product NDC
59555-117
11-digit product format
595550117
Labeler code
59555
Product ID
59555-117_ead4f3b4-228f-4c7f-88f9-44d2618b717e
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTINOXATE, OXYBENZONE, and OCTISALATE
Dosage form
LOTION
Route
TOPICAL
Labeler
R & R Lotion, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-26
Substance
ZINC OXIDE; OCTINOXATE; OXYBENZONE; OCTISALATE
Active strength
67.3; 57.5; 45; 38.3 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
I.C. Industrial Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE67.3 mg/mL
OCTINOXATE57.5 mg/mL
OXYBENZONE45 mg/mL
OCTISALATE38.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal 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
b89d687a-7b36-4643-9817-765d4710ca60Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-117-01I.C. Industrial Sunscreen5 mL in 1 PACKETLOTION51
59555-117-04I.C. Industrial Sunscreen59 mL in 1 BOTTLE, DISPENSINGLOTION591
59555-117-07I.C. Industrial Sunscreen118 mL in 1 BOTTLE, DISPENSINGLOTION1181
59555-117-08I.C. Industrial Sunscreen236 mL in 1 BOTTLE, DISPENSINGLOTION2361
59555-117-10I.C. Industrial Sunscreen946 mL in 1 BOTTLE, PUMPLOTION9461
59555-117-11I.C. Industrial Sunscreen3785 mL in 1 BOTTLE, PUMPLOTION37851
59555-117-13I.C. Industrial Sunscreen50 mL in 1 BOTTLE, PUMPLOTION501
59555-117-16I.C. Industrial Sunscreen4 mL in 1 PACKETLOTION41

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 86 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45SUNSCREEN SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47ddf752-cae2-313f-e063-6294a90a7e3a2026-01-08WarningsExact identifier
application number: M020
St Moriz suncare face sunscreen spf50OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df072e-151f-eb30-e063-6294a90a4eeb2026-01-08WarningsExact identifier
application number: M020
SUNSCREEN GLOWINGAVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df0de5-012a-c896-e063-6394a90a9cef2026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35f6-63d2-3d26-e053-2991aa0a5b442026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35a1-a139-1974-e053-2a91aa0a20b62026-01-08WarningsExact identifier
application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral SunscreenSPF 30EVI LABS258b7b7c-a3f2-172c-e063-6394a90aec6a2026-01-08WarningsExact identifier
application number: M020
DMK Ultrascreen Mineral SunscreenZINC OXIDEDanne Montague King3f022275-c1e5-2704-e063-6294a90a4a812026-01-08WarningsExact identifier
application number: M020
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 SheerREJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEERAtlantic Medical Products, LLC47e5198e-7bf6-72a8-e063-6294a90a7ec52026-01-08WarningsExact identifier
application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUMINDE WILD SUN DEFENSE GLOW DROPSINDE WILD PRIVATE LIMITED47e57407-2925-09ca-e063-6294a90a49ec2026-01-08WarningsExact identifier
application number: M020
NIDA Invisible Fit SunscreenSUNSCREENProso Corp47ed3b62-45ef-b67a-e063-6294a90a317b2026-01-08WarningsExact identifier
application number: M020
Organic Matters SPF 50 SunscreenZINC OXIDEVeganic SKN Limited12f37c8d-07f0-3e75-e063-6294a90a2cdf2026-01-08WarningsExact identifier
application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50ZINC OXIDEVeganic SKN Limited161a7209-10d8-928c-e063-6394a90a41392026-01-08WarningsExact identifier
application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and faceZINC OXIDEVeganic SKN Limited1a97169e-67be-3d25-e063-6294a90a3b882026-01-08WarningsExact identifier
application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLC1208d0f8-bb12-4574-b70e-3a76b11a64c72026-01-07WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKDC/One Development Corporation, Inc.259f3fe3-2967-6c05-e063-6394a90a9e452026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group4084dd98-357f-4011-b0d4-db6536d2931f2026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group9b4acc5e-fdaf-4fcb-83a9-69e430dd43de2026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Sensitive Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Groupb42261c5-fa6e-4bb3-93c0-97032ab9f7162026-01-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59555-117-01595550117015 mL in 1 PACKET (59555-117-01) 5 ml2022-05-26NoNoCurrent
59555-117-045955501170459 mL in 1 BOTTLE, DISPENSING (59555-117-04) 59 ml2022-05-26NoNoCurrent
59555-117-0759555011707118 mL in 1 BOTTLE, DISPENSING (59555-117-07) 118 ml2022-05-26NoNoCurrent
59555-117-0859555011708236 mL in 1 BOTTLE, DISPENSING (59555-117-08) 236 ml2022-05-26NoNoCurrent
59555-117-1059555011710946 mL in 1 BOTTLE, PUMP (59555-117-10) 946 ml2022-05-26NoNoCurrent
59555-117-11595550117113785 mL in 1 BOTTLE, PUMP (59555-117-11) 3785 ml2022-05-26NoNoCurrent
59555-117-135955501171350 mL in 1 BOTTLE, PUMP (59555-117-13) 50 ml2022-05-26NoNoCurrent
59555-117-16595550117164 mL in 1 PACKET (59555-117-16) 4 ml2022-05-26NoNoCurrent