StriVectin Advanced SPF Full Screen

Manufacturer
Canadian Custom Packaging Company
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:42:31

Label at a glance#

ProductStriVectin Advanced SPF Full Screen Clear Finish
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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 generously 15 minutes before sun exposure and as needed reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time inthe sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protectionmeasures including: limit time in the sun, ...

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 8.5%

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact

a Poison Control Center right away.

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 generously 15 minutes before sun exposure and as needed
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time inthe sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protectionmeasures 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

Isohexadecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Polyester-8, Polymethylsilsesquioxane/Silica Crosspolymer, Glyceryl Dibehenate, VP/Hexadecene Copolymer, Fragrance (Parfum), Myristyl Nicotinate, Glycine Soja (Soybean) Oil, Tocopherol, Argania Spinosa (Argan) Kernel Oil, Bis(Cyano Butylacetate) Anthracenediylidene, Polyglyceryl-3 Diisostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Cocos Nucifera (Coconut) Oil, Brassica Campestris (Rapeseed) Seed Oil, Quercus Suber Bark Extract, Retinyl Palmitate, Glycyrrhiza Glabra (Licorice) (Licorice) Root Extract, 7-Dehydrocholesterol, Ascorbyl Palmitate, Oak Root Extract, Althaea Officinalis Root Extract, Oryza Sativa (Rice) Bran Extract, Limonene, Citral, Linalool

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_Adv SPF Full Screen_Clear01b UC_Adv SPF Full Screen_Clear

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54291-051-01StriVectin Advanced SPF Full ScreenClear Finish44 mL in 1 TUBELOTION442
54291-051-01StriVectin Advanced SPF Full ScreenClear Finish1 in 1 BOXLOTION12
54291-051-02StriVectin Advanced SPF Full ScreenClear Finish1 mL in 1 PACKETLOTION12
54291-051-03StriVectin Advanced SPF Full ScreenClear Finish7 mL in 1 TUBELOTION72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54291-051STRIVECTIN ADVANCED SPF FULL SCREEN CLEAR FINISH (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CANADIAN CUSTOM PACKAGING COMPANY]24 package rows20241213_b3afec4d-a746-59f6-e053-2a95a90a8f99.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
54291-05154291-051-01, 54291-051-02, 54291-051-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

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
2902f400-3739-7619-e063-6294a90ad074b3afec4d-a746-59f6-e053-2a95a90a8f992024-12-11WarningsExact identifier
spl id: 2902f400-3739-7619-e063-6294a90ad074
spl set id: b3afec4d-a746-59f6-e053-2a95a90a8f99

Reported adverse events (FAERS/openFDA)#

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