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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate 7.50%, Octisalate 5.00%, Octocrylene 5.00%, Avobenzone 3.00%, Sunscreen
Available from:
Alfa Distribution and Imports
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
*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.
Authorization status:
OTC monograph not final
Authorization number:
72872-137-17

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

avobenzone cream

Alfa Distribution and Imports

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Protetor Solar Grip Action FPS 40

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:

PROTETOR SOLAR GRIP ACTION FPS 40

octinoxate, octisalate, octocrylene, avobenzone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:728 72-137

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

75 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

50 mg in 1 mL

Alfa Distribution and Imports

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

50 mg in 1 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

30 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

HELIANTHUS ANNUUS FLO WERING TO P (UNII: BKJ0 J3D1BP)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

CO RN (UNII: 0 N8 6 7270 7O)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:728 72-137-17

170 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 5/10 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 5/10 /20 19

Labeler -

Alfa Distribution and Imports (944443265)

Revised: 5/2019

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