FDA.reportPublic FDA data

Solar Defense Tinted

Manufacturer
HydroPeptide LLC
Effective date
2023-12-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:03:45

Label at a glance#

ProductSolar Defense Tinted
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures. Limit time in the sun...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (2.5%)

Zinc Oxide (6%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use 

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product 

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

1,2-Hexanediol, Acrylates/Ammonium Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Alpinia Galanga Extract, Alumina, Benzyl Benzoate, Benzyl Salicylate, Biotin, Boron Nitridem, Butylene Glycol, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Caprylyl Methicone, Cellulose Acetate, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Citral, Citric Acid Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Cyclophentasiloxane, Dimethicone , Disodium EDTA, Ethylhexyl Palmitate, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Hexyl Cinnamal, Hydrolyzed Yeast Protein, Hydroxyethyl Acylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Lilial, Limonene, Niacinamide, Panthenol, PEG-100 Stearate, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Propanediol, Propylene Glycol Stearate, Propylene Glycol, Pyridoxine HCl, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Thermus Thermophilus Ferment, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Water, Xanthan Gum

Other Information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1.800.932.9873

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60934-005-01Solar Defense Tinted50 mL in 1 TUBECREAM505
60934-005-01Solar Defense Tinted1 in 1 BOXCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60934-005SOLAR DEFENSE TINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HYDROPEPTIDE LLC]5Current NDC, Legacy NDC, 2 package rows20231210_45ec77c5-5ec4-0e51-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 2 · 56 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60934-00560934-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 53 matching rows.

Name, UNII, Kind table
NameUNIIKind
1,2-HEXANEDIOLTR046Y3K1GIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM OXIDELMI26O6933IACT
BENZYL BENZOATEN863NB338GIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
BIOTIN6SO6U10H04IACT
BORON NITRIDE2U4T60A6YDIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CELLULOSE ACETATE3J2P07GVB6IACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
CHLORPHENESINI670DAL4SZIACT
CITRALT7EU0O9VPPIACT
CUCUMBERYY7C30VXJTIACT
CYCLOMETHICONENMQ347994ZIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYL PALMITATE2865993309IACT
ACAI46AM2VJ0AWIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
LIMONENE, (+)-GFD7C86Q1WIACT
NIACINAMIDE25X51I8RD4IACT
PANTHENOLWV9CM0O67ZIACT
PEG-100 STEARATEYD01N1999RIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYSORBATE 60CAL22UVI4MIACT

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
Solar Defense TintedTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLC45ec77c5-5ec4-0e51-e054-00144ff8d46c2023-12-09WarningsExact identifier
ndc (package): 60934-005-01
ndc (product): 60934-005
ndc11 (package): 60934000501
spl id: 0c0e9512-2d15-e1ff-e063-6294a90aea1a
spl set id: 45ec77c5-5ec4-0e51-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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