SPORT SUNSCREEN SPF 50 TOPCARE- homosalate 6.00% octinoxate 7.50% octisalate 5.00% octocrylene 10.00% zinc oxide 8.00% stick

Sport Sunscreen SPF 50 by

Drug Labeling and Warnings

Sport Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by TopCo, Product Quest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                   Purpose
Homosalate 6.0%....................................................................Sunscreen
Octinoxate 7.5%......................................................................Sunscreen
Octisalate 5.0%.......................................................................Sunscreen
Octocrylene 10.0%..................................................................Sunscreen
Zinc Oxide 8.0%......................................................................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn higher SPF gives more sunburn
protection retains SPF after 40 minutes of activity in the water
provides high protection against sunburn

WARNINGS

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
Apply liberally 15 minutes before sun exposure. Reapply: after 40
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 value 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-sleeved shirts, pants,
hats, and sunglasses. Children under 6 months of age: ask a doctor

OTHER SAFETY INFORMATION

Other information protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients
Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Ceresin,
Chamomilla Recutita (Matricaria) Flower Extract, Copernicia Cerifera
(Carnauba) Wax, Dimethicone, Ethyl Macadamiate, Ethylhexyl Palmitate,
Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polyisobutene,
Malic Acid, Mentha Piperita (Peppermint) Oil, Octyldodecanol,
Polyethylene, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate,
Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane.

Questions? 1-888-423-0139

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPORT SUNSCREEN SPF 50  TOPCARE
homosalate 6.00% octinoxate 7.50% octisalate 5.00% octocrylene 10.00% zinc oxide 8.00% stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-865
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	6 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Ceresin (UNII: Q1LS2UJO3A)
CHAMOMILE (UNII: FGL3685T2X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
Dimethicone (UNII: 92RU3N3Y1O)
Ethyl Macadamiate (UNII: ANA2NCS6V1)
Ethylhexyl Palmitate (UNII: 2865993309)
SUNFLOWER OIL (UNII: 3W1JG795YI)
Malic Acid (UNII: 817L1N4CKP)
PEPPERMINT OIL (UNII: AV092KU4JH)
Octyldodecanol (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
Propylparaben (UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Triethoxycaprylylsilane (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-865-01	14 g in 1 CONTAINER; Type 0: Not a Combination Product	01/25/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/25/2013

Labeler - TopCo (006935977)

Registrant - Product Quest (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest		927768135	manufacture(36800-865)