SPORT SUNSCREEN SPF 45- avobenzone, homosalate, octocrylene, octisalate lotion

Sport Sunscreen SPF 45 by

Drug Labeling and Warnings

Sport Sunscreen SPF 45 by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other protective measures including:

• limit time in the sun, especially from 10am to 2pm
• and wear long-sleeved shirts, pants, hats and sunglasses.

PURPOSE

Sunscreen

WARNINGS

For external use only. Do not use on broken or damaged skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INACTIVE INGREDIENT

Water (Aqua), Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Dimethicone, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Aloe Barbadensis Leaf Juice (1), Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract (1), Panax Ginseng Root Extract, Tocopheryl Acetate, Alcohol (1), Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate

(1) Certified Organic Ingredient

INDICATIONS & USAGE

• 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPORT SUNSCREEN SPF 45 
avobenzone, homosalate, octocrylene, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
GINKGO (UNII: 19FUJ2C58T)
ASIAN GINSENG (UNII: CUQ3A77YXI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
XANTHAN GUM (UNII: TTV12P4NEE)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2020-4	113 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/19/2019

Labeler - The Hain Celestial Group, Inc (117115556)

Registrant - The Hain Celestial Group, Inc (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc		117115556	manufacture(61995-2020)