FDA.reportPublic FDA data

HA Physical Tint SPF 44

Manufacturer
Private Label Skin Care
Effective date
2025-02-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:57:38

Label at a glance#

ProductHA Physical Tint SPF 44
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

• Helps prevent sunburn • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

• Apply liberally on a clean dry face, avoiding delicate eye area 15 minutes before sun exposure • reapply: • after 40 minutes of swimming • or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher ...

Storage and handling

• protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10%

Titanium Dioxide 5.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use • on damaged or broken skin

When using this product
• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally on a clean dry face, avoiding delicate eye area 15 minutes before sun exposure • reapply: • after 40 minutes of swimming • or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.– 2 p.m • wear long-sleeved shirts pants, hats, and sunglasses • children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Cyclopentasiloxane, Caprylyl Methicone, C12-15 Alkyl Benzoate, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Octyldodecyl Neopentanoate, Dimethicone, Alumina, Sodium Chloride, Sodium Hyaluronate, Tocopherol, Ascorbyl Palmitate, Polyhydroxystearic Acid, Methicone, Disteardimonium Hectorite, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Propylene Carbonate, 1,2 Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

SPL UNCLASSIFIED SECTION

brand MD

Broad Spectrum Sunscreen
Water Resistant (40 Minutes)

Titanium Dioxide 10%
Zinc Oxide 5.5%
Hyaluronic Acid

MEDICAL GRADE

SHIELD

RECOMMENDED FOR
• COMBO  • OILY
• DRY       • SENSITIVE
• NORMAL

GREEN LEAF PROGRAM

NOT TESTED ON ANIMALS

Distributed by:
brandMD®
Canoga Park, CA 91304
(818) 534-3180
www.brandMD.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

45314531

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
72957-006-01HA Physical Tint SPF 4459 g in 1 BOTTLE, PUMPCREAM595

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72957-006HA PHYSICAL TINT SPF 44 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [PRIVATE LABEL SKIN CARE]5Current NDC, Legacy NDC, 1 package rows20250323_a5e19d77-703e-41e0-9a02-19227dc6c819.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72957-00672957-006-01
39765-022

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
ALUMINUM OXIDELMI26O6933IACT
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL PALMITATEQN83US2B0NIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
METHICONE (20 CST)6777U11MKTIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PROPYLENE CARBONATE8D08K3S51EIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
ndc (package): 72957-006-01
ndc (product): 72957-006
ndc11 (package): 72957000601
spl id: da3bb6d7-fcb2-4f71-aacd-d57fcea8a21c
spl set id: a5e19d77-703e-41e0-9a02-19227dc6c819

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.