FDA.reportPublic FDA data

Protetor Solar Grip Action FPS 40

Manufacturer
Alfa Distribution and Imports
Effective date
2019-05-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:24:22

Label at a glance#

ProductProtetor Solar Grip Action FPS 40
Active ingredientOCTINOXATE, OCTISALATE, OCTOCRYLENE, 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 skin aging caused by the sun.

Dosage and administration

* Apply liberally 15-minutes before sun exposure. * Reapply: - At least every two-hours. * Immediately after swimming, sweating or towel drying. SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscren with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: -...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.50%

Octisalate 5.00%

Octocrylene 5.00%

Avobenzone 3.00%

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

OTC - DO NOT USE SECTION

* on damaged or broken skin.

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

Stop use and consult physician 

OTC - STOP USE SECTION

*if irritation or rash develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

* If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

* Apply liberally 15-minutes before sun exposure.

* Reapply: - At least every two-hours.

* Immediately after swimming, sweating or towel drying. SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscren with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

- Limit time in the sun, especially between 10am and 2pm.

-Wear long sleeve shirts, pants, hats and sunglasses.

- For children under 6-months, consult a physician. 

OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, PEG-100 Stearate, Phenoxyethanol, Polysorbate-80, Styrene/Acrylates Copolymer, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

*Protect this product from excessive heat and direct sunlight.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
72872-13772872-137-17

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
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CORN0N8672707OIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML · Source PDF

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
074b13e3-c70d-2a43-e063-6294a90aa0e1865cc8ca-b3cf-4870-a938-cd4d0fa058342023-10-09WarningsExact identifier
spl set id: 865cc8ca-b3cf-4870-a938-cd4d0fa05834

Reported adverse events (FAERS/openFDA)#

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