United States - English - NLM (National Library of Medicine)
DERMA-E ALL SPORT PERFORMANCE SUNSCREEN SPF 50- octocrylene, octisalate,
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.
Derma-E All Sport Performance Sunscreen Spray SPF 50
Octocrylene 10%, Octisalate 5%,
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.
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.
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.
Protect this product from excessive heat and direct sunlight.
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
DERMA-E ALL SPORT PERFORMANCE SUNSCREEN SPF 50
octocrylene, octisalate, avobenzone spray
Product T ype
HUMAN OTC DRUG
Ite m Code (Source )
NDC:51326 -0 44
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)
10 0 mg in 1 mL
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
50 mg in 1 mL
AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)
30 mg in 1 mL
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 )
Marketing Start Date
Marketing End Date
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
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
0 4/10 /20 19
T opiderm Inc. (049121643)