FDA.reportPublic FDA data

SPF50 Moisturizer with Aloe, Green Tea and Shea Butter

Product NDC
83695-002
11-digit product format
836950002
Labeler code
83695
Product ID
83695-002_4bbf94a2-1af9-523e-e063-6394a90a9fc5
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Audrey Morris Cosmetics International, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-01
Substance
ZINC OXIDE
Active strength
22.3 g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
SPF50 Moisturizer with Aloe, Green Tea and Shea Butter
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE22.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92960e14-9845-49aa-b3ce-c8023aa109b6Available 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
83695-002-01SPF50 Moisturizer with Aloe, Green Tea and Shea Butter113 g in 1 BOTTLECREAM1131
83695-002-01SPF50 Moisturizer with Aloe, Green Tea and Shea Butter1 in 1 CARTONCREAM11

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
83695-002-01836950002011 BOTTLE in 1 CARTON (83695-002-01) / 113 g in 1 BOTTLE1 bottle2026-03-01NoNoCurrent