DERMA-E ALL SPORT PERFORMANCE SUNSCREEN SPF 50- octocrylene, octisalate, avobenzone spray

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

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Active ingredient:
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)
Available from:
Topiderm Inc.
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:
51326-044-00

DERMA-E ALL SPORT PERFORMANCE SUNSCREEN SPF 50- octocrylene, octisalate,

avobenzone spray

Topiderm Inc.

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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Derma-E All Sport Performance Sunscreen Spray SPF 50

Drug Facts

Active Ingredient

Octocrylene 10%, Octisalate 5%,

Avobenzone 3%

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 a sunscreen with broad spectrum SPF of 15 or

higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. – 2 p.m.

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

Reapply at least every 2 hours.

For children under 6-months, consult a physician.

Other information

Protect this product from excessive heat and direct sunlight.

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate

(Vitamin C), Butyloctyl Salicylate, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus

(Cucumber) Fruit Extract, Parfum (Fragrance), SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Questions or comments?

Call toll free 1-800-933-9344 or visit dermae.com

Package Labeling:

DERMA-E ALL SPORT PERFORMANCE SUNSCREEN SPF 50

octocrylene, octisalate, avobenzone spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51326 -0 44

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

OCTOCRYLENE

10 0 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

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

AVOBENZONE

30 mg in 1 mL

Topiderm Inc.

Inactive Ingredients

Ingredient Name

Stre ng th

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

ASCO RBYL PALMITATE (UNII: QN8 3US2B0 N)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

CHAMO MILE (UNII: FGL36 8 5T2X)

CUCUMBER (UNII: YY7C30 VXJT)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51326 -0 44-0 0

177 mL in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 4/10 /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 4/10 /20 19

Labeler -

T opiderm Inc. (049121643)

Revised: 4/2019

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