FDA.reportPublic FDA data

Protect SPF 30

Manufacturer
Hunter Vaughan, LLC | 6 Degrees Collective
Effective date
2023-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:26

Label at a glance#

ProductProtect SPF 30
Active ingredientZINC OXIDE, OCTISALATE, AVOBENZONE
Label structure7 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 aging caused by the sun.

Dosage and administration

Shake Well After cleansing and toning, apply generously 15 minutes prior to sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Immediately after towel drying. At least every 2 hours. Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum value of SPF 15 or higher an...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Zinc Oxide 11.5%Sunscreen
Octisalate 2.5%Sunscreen
Avobenzone 2.0%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 aging caused by the sun.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake Well

After cleansing and toning, apply generously 15 minutes prior to sun exposure.

Reapply at least every two hours.

Use a water-resistant sunscreen if swimming or sweating. Immediately after towel drying. At least every 2 hours.

Sun Protection Measures

SPL UNCLASSIFIED SECTION

Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glyceryl Stearate, Cetearyl Alcohol, Cetyl Alcohol, Caprylic/Capric Triglycerides, Glycerin, Ethyl Macadamiate, Ethoxydiglycol, C12-15 Alkyl Benzoate, Olea Europaea (Olive) Fruit Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Carbomer, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Natural)

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burke Williams

H2v
[Protect]

Protect SPF 30

daytime moisturizer

2 fl oz 50 ml

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70693-231-012025-01-30C16284748780-11030e365-0869-111a-e063-dadaa90a10e2Protect SPF 30
70693-231-012024-01-30C16284748780-11030e365-0869-111a-e063-dadaa90a10e2Protect SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70693-231-01Protect SPF 3059.15 mL in 1 BOTTLELOTION59.151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70693-231PROTECT SPF 30 (ZINC OXIDE, OCTISALATE, AND AVOBENZONE) LOTION [HUNTER VAUGHAN, LLC]11 package rows20231005_3a854777-e565-4406-af4e-339a703e04cd.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70693-23170693-231-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
ETHYL MACADAMIATEANA2NCS6V1IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OLIVE OIL6UYK2W1W1EIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FRAGRANCE 135765EM498GW35IACT

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
ec8de41f-e89d-46df-ae63-8b1d14e6284d3a854777-e565-4406-af4e-339a703e04cd2023-09-01WarningsExact identifier
spl id: ec8de41f-e89d-46df-ae63-8b1d14e6284d
spl set id: 3a854777-e565-4406-af4e-339a703e04cd

Reported adverse events (FAERS/openFDA)#

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