FDA.reportPublic FDA data

THERAVITARX SPF 50+ Sunscreen Stick

Manufacturer
Theravita LLC
Effective date
2026-07-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-25 01:02:38

Label at a glance#

ProductSPF 50 plus Sunscreen
Active ingredientOCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE
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

Apply liberally 15 minutes before sun exposure. • Reapply: - after 80 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...

Storage and handling

protect this product from excessive heat and direct sun keep outer card for full drug facts

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octocrylene 8%

Octisalate 5%

Octinoxate 7.5%

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.

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash 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 15 minutes before sun exposure.

    • Reapply:

    - after 80 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. to 2 p.m.

    • wear long-sleeved shirts, pants, hats and sunglasses.

    Children under 6 months:

    Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • keep outer card for full drug facts

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Ethylhexyl Palmitate
  • Synthetic Wax
  • Polyethylene
  • * Microcrystalline Wax
  • * Polyglyceryl-10 Stearate
  • * Hydrogenated Polyisobutene
  • * Silica
  • * Tocopherol (Vitamin E)
  • * Bisabolol
  • * Aloe Barbadensis Leaf Extract
  • * Fragrance (optional)
  • * Phenoxyethanol
  • * Caprylyl Glycol
  • * Ethylhexylglycerin

SPL UNCLASSIFIED SECTION

Theravita LLC

Valley Stream, NY 11580

USA

PRINCIPAL DISPLAY PANEL - 15 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THERAVITARX Sunscreen Stick

Broad Spectrum SPF 50+ PA+++

Net Weight: 15 g (0.53 oz)

For external use only.

lable01lable01

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87807-00187807-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
ETHYLHEXYL PALMITATE2865993309IACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
POLYETHYLENEUG00KM4WR7IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
HYDROGENATED POLYISOBUTENE 87YR4ZFS62EIACT
SILICAETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
BISABOLOL24WE03BX2TIACT
ALOEV5VD430YW9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
SPF 50 plus SunscreenTITANIUM DIOXIDE AND ZINC OXIDETheravita LLCd8e276cc-0292-499d-9075-a83a2d3fafcc2026-07-02WarningsExact identifier
ndc (package): 87807-001-01
ndc (product): 87807-001
ndc11 (package): 87807000101
spl id: 55a25daf-4da3-7367-e063-6394a90a5b33
spl set id: d8e276cc-0292-499d-9075-a83a2d3fafcc

Reported adverse events (FAERS/openFDA)#

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