PROTETOR SOLAR GRIP ACTION FPS 40- octinoxate, octisalate, octocrylene, avobenzone cream

Protetor Solar Grip Action FPS 40 by

Drug Labeling and Warnings

Protetor Solar Grip Action FPS 40 by is a Otc medication manufactured, distributed, or labeled by Alfa Distribution and Imports. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Octinoxate 7.50%

Octisalate 5.00%

Octocrylene 5.00%

Avobenzone 3.00%

PURPOSE

Sunscreen

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.

WARNINGS:

*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 consult physician 

*if irritation or rash develops.

Keep out of reach of children.

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

DIRECTIONS:

* 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:

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:

*Protect this product from excessive heat and direct sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

PROTETOR SOLAR GRIP ACTION FPS 40 
octinoxate, octisalate, octocrylene, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72872-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72872-137-17	170 mL in 1 TUBE; Type 0: Not a Combination Product	05/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/10/2019

Labeler - Alfa Distribution and Imports (944443265)