FDA.reportPublic FDA data

Prime Time Daily Protecting Primer SPF 30

Manufacturer
Autumn Harp Inc.
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:06:47

Label at a glance#

ProductPrime Time Daily Protecting Primer SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 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

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.1%

Zinc Oxide 10.49%

INDICATIONS & USAGE SECTION

Sunscreen

Sunscreen

Uses

OTC - WHEN USING 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

INSTRUCTIONS FOR USE SECTION

  • For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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 am - 2 pm
  • wear long sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Undecane, Polyglyceryl-6 Polyricinoleate, Tapioca Starch, Glycerin, Tridecane, Magnesium Sulfate, Polyglyceryl-2 Isostearate, Tocopherol, Hydrogenated Vegetable Oil, Phenoxyethanol, Glyceryl Isostearate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Propanediol, Bisabolol, Stearic Acid, Iron Oxide (CI 77492), Alumina, 1,2-Hexanediol, Isononyl Isononanoate, Camellia Japonica Seed Oil, Theobroma Cacao (Cocoa) Extract, Butylene Glycol, Isopropyl Myristate, Isostearic Acid, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Biosaccharide gum-4, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Propylene Carbonate.

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-888-795-4747

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image Content

TubeTubeCartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51514-0364-1Prime Time Daily Protecting Primer SPF 3030 g in 1 TUBELOTION301
51514-0364-2Prime Time Daily Protecting Primer SPF 301 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51514-0364PRIME TIME DAILY PROTECTING PRIMER SPF 30 (SPF 30 PRIME TIME PRIMER) LOTION [AUTUMN HARP INC.]1Current NDC, 2 package rows20240106_f2619092-3e7f-5105-e053-2a95a90a3f5a.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51514-036451514-0364-1, 51514-0364-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TOCOPHEROLR0ZB2556P8IACT
FERRIC OXIDE RED1K09F3G675IACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
UNDECANEJV0QT00NUEIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
STARCH, TAPIOCA24SC3U704IIACT
TRIDECANEA3LZF0L939IACT
STEARIC ACID4ELV7Z65APIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
THEOBROMA CACAO WHOLEEB048G1S9JIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
POLYGLYCERYL-2 ISOSTEARATE7B8OE71MQCIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOSTEARIC ACIDX33R8U0062IACT
BIOSACCHARIDE GUM-49XRL057X90IACT
PROPYLENE CARBONATE8D08K3S51EIACT
HYDROGENATED PALM KERNEL OILFM8D1RE2VPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PROPANEDIOL5965N8W85TIACT
ALUMINUM OXIDELMI26O6933IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
CAMELLIA JAPONICA SEED OILU37N0S910TIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
STEARALKONIUM HECTORITEOLX698AH5PIACT

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
Prime Time Daily Protecting Primer SPF 30SPF 30 PRIME TIME PRIMERAutumn Harp Inc.f2619092-3e7f-5105-e053-2a95a90a3f5a2024-01-03WarningsExact identifier
ndc (package): 51514-0364-2
ndc (package): 51514-0364-1
ndc (product): 51514-0364
ndc11 (package): 51514036401
ndc11 (package): 51514036402
spl id: f2619092-3e80-5105-e053-2a95a90a3f5a
spl set id: f2619092-3e7f-5105-e053-2a95a90a3f5a

Reported adverse events (FAERS/openFDA)#

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