SPORT SUNSCREEN SPF 50 TOPCARE- avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 5.00% spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

Available from:

Topco

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Avobenzone - 3.00% Homosalate - 10.00% Octisalate - 5.00% Octocrylene - 5.00%                                  Sunscreen - helps prevent sunburn - if used as directed with other sun protection messures (see Directions ) decreases the risk of skin cancer and early skin aging caused by sun.

Authorization status:

OTC monograph not final

Summary of Product characteristics

SPORT SUNSCREEN SPF 50 TOPCARE- AVOBENZONE 3.00% HOMOSALATE 10.00%
OCTISALATE
5.00% OCTOCRYLENE 5.00% SPRAY
TOPCO
_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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DRUG FACTS
ACTIVE INGREDIENTS PURPOSE
Avobenzone - 3.00%
Homosalate - 10.00%
Octisalate - 5.00%
Octocrylene - 5.00% Sunscreen
- helps prevent sunburn
- if used as directed with other sun protection messures (see
DIRECTIONS) decreases the risk of skin
cancer and early skin aging caused by 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 ASK A DOCTOR IF rash occurs
KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical
help or contact a Poison Control
Center right away.
DIRECTIONS
spray liberally and spread evenly by hand 15 minutes before sun
exposure
• reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours
• 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 a
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
• children under 6 months: Ask a doctor
INACTIVE INGREDIENTS
Acrylates/Dimethicone Copolymer
Acrylates/Octylacrylamide Copolymer
Alcohol Denat.
Aloe Barbadensis Leaf Extract
Cyclopentasiloxane
Dimethicone
Fragrance
Polyester-8
PPG-5-Ceteth-20
Tocopheryl Acetate
Trisiloxane
SPORT SUNSCREEN SPF 50 TOPCARE
avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 5.00%
spray
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:36 8 0 0 -8 6 8
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME