FDA.reportPublic FDA data

ALLIES OF SKIN The One SPF-50 Invisible Sunscreen

Product NDC
83852-438
11-digit product format
838520438
Labeler code
83852
Product ID
83852-438_37234241-69a6-fc24-e063-6394a90a9604
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form
GEL
Route
TOPICAL
Labeler
ALLIES GROUP PTE. LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-11
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
30; 70; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
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
ALLIES OF SKIN The One SPF-50 Invisible Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE70 mg/mL
OCTOCRYLENE100 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
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
36e1c61c-33ab-4a5d-853d-119c29632b08Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83852-438-03ALLIES OF SKIN The One SPF-50 Invisible Sunscreen3 mL in 1 PACKETGEL34
83852-438-20ALLIES OF SKIN The One SPF-50 Invisible Sunscreen1 in 1 BOXGEL14
83852-438-20ALLIES OF SKIN The One SPF-50 Invisible Sunscreen20 mL in 1 TUBEGEL204
83852-438-50ALLIES OF SKIN The One SPF-50 Invisible Sunscreen1 in 1 BOXGEL14
83852-438-50ALLIES OF SKIN The One SPF-50 Invisible Sunscreen50 mL in 1 TUBEGEL504
83852-438-90ALLIES OF SKIN The One SPF-50 Invisible Sunscreen1 in 1 BOXGEL14
83852-438-90ALLIES OF SKIN The One SPF-50 Invisible Sunscreen90 mL in 1 TUBEGEL904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83852-438ALLIES OF SKIN THE ONE SPF-50 INVISIBLE SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [ALLIES GROUP PTE. LTD.]3Current NDC, 7 package rows20250131_36e1c61c-33ab-4a5d-853d-119c29632b08.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 147 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Based Foam Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32465271-abb9-d03f-e063-6294a90a990e2025-12-08Exact identifier
application number: M020
Mineral Based Foam Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32486bfb-0cc8-0283-e063-6394a90a99672025-12-08Exact identifier
application number: M020
Harrys Daily Facial SPF Broad SpectrumZINC OXIDEHarry's, Inc.39fdde34-45ec-bc22-e063-6394a90a7dce2025-12-08WarningsExact identifier
application number: M020
Healthy Mineral Sunscreen Brightening plus TintZINC OXIDEZEN DERMATOLOGY, INC.31e32e9c-9e0b-b678-e063-6294a90a66f52025-12-08Exact identifier
application number: M020
Healthy Mineral Sunscreen No Shine plus TintZINC OXIDEZen Dermatology, Inc.31576340-cb11-d944-e063-6294a90adef22025-12-08WarningsExact identifier
application number: M020
Healthy Mineral Sunscreen No Shine - No TintTITANIUM DIOXIDE, ZINC OXIDEZen Dermatology, Inc.31572a16-5f60-565f-e063-6394a90ab8c92025-12-08WarningsExact identifier
application number: M020
Healthy Mineral Sunscreen Face and BodyZINC OXIDEZen Dermatology, Inc.31e376b4-098f-34d7-e063-6394a90a17722025-12-08Exact identifier
application number: M020
AcneFix Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.315894b7-ac1b-0982-e063-6294a90ab8792025-12-08Exact identifier
application number: M020
Shunly Natural Cover SPF50TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Carea64e373b-b3f6-4024-b5f5-253783485cd62025-12-08WarningsExact identifier
application number: M020
AcneFix Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.31583c7e-365a-d899-e063-6394a90aa63f2025-12-08Exact identifier
application number: M020
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334ec844-5560-50f7-e063-6394a90a01be2025-12-08Exact identifier
application number: M020
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334f90d6-68e5-db37-e063-6294a90a5fb12025-12-08Exact identifier
application number: M020
Skin Apeel Pure Protect SPF 40 Broad SpectrumZINC OXIDESkin Apeel, Inc.18e78c7f-1523-a4f4-e063-6394a90aed972025-12-08WarningsExact identifier
application number: M020
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c44baf4-9555-faad-e063-6294a90ab24f2025-12-08WarningsExact identifier
application number: M020
Glow StickTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c54b857-c017-a953-e063-6394a90a38df2025-12-08WarningsExact identifier
application number: M020
Lip ShieldTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c545e55-3f55-842b-e063-6394a90ae48e2025-12-08WarningsExact identifier
application number: M020
Bare Barrier SportTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c580794-eda3-de57-e063-6294a90a03032025-12-08WarningsExact identifier
application number: M020
Flawless Brightening SunscreenTITANIUM DIOXIDE, ZINC OXIDEFlawless Skin Care LLC312e9ca0-a388-a546-e063-6294a90a15d62025-12-08WarningsExact identifier
application number: M020
Mineral SPF 40, protectTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2f8859cf-8277-6ea9-e063-6294a90a1a752025-12-08WarningsExact identifier
application number: M020
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb19ed7-8cee-ce80-e063-6394a90ad3dc2025-12-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83852-438-03838520438033 mL in 1 PACKET (83852-438-03) 3 ml2023-12-11YesNoCurrent
83852-438-20838520438201 TUBE in 1 BOX (83852-438-20) / 20 mL in 1 TUBE1 tube2024-06-19NoNoCurrent
83852-438-50838520438501 TUBE in 1 BOX (83852-438-50) / 50 mL in 1 TUBE1 tube2023-12-11NoNoCurrent
83852-438-90838520438901 TUBE in 1 BOX (83852-438-90) / 90 mL in 1 TUBE1 tube2025-05-15NoNoCurrent