SEA AND SKI SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Sea and Ski SPF 50 by

Drug Labeling and Warnings

Sea and Ski SPF 50 by is a Otc medication manufactured, distributed, or labeled by Cross Brands Contract Filling. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.0%, Homsalate 15.0%, Octisalate 7.0%, Octocrylene 8.0%

Purpose

Sunscreen

Uses

helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the reisk 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 Ask a Doctor if

rash occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Cener right away.

Directions

apply liberally 15 minutes before sun exposure. reapply:

• after 80 minutes of swimming or sweting
• immediately after towl 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: Ask a doctor.

Other information

protect this product from excessive heat and direct sun

may stain some fabrics, wood, plastics, vinyl

for use on skin only

store between 20°-25°C (68°-77°F).

Inactive

acrylates copolymer, acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylene glycol, carbomer, dimethicone, disodium EDTA, ethylhexyl palmitate, ethylhexylglycerin, glycerin, hydroxypropyl methylcellulose, neopentyl glycol diheptanoate, phenoxyethanol, simmondsia chinensis (jojoba) extract, sorbitan monooleate, styrene/ acrylates copolymer, triethanolamine, water

Questions or comments?

Call 855-sea-n-ski (855-732-6754) or visit www. seaNski.com

Front Label

INGREDIENTS AND APPEARANCE

SEA AND SKI SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73440-2154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.275 g  in 42.5 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.375 g  in 42.5 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.975 g  in 42.5 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.4 g  in 42.5 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	20.59 g  in 42.5 g

Product Characteristics
Color	white (Opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73440-2154-1	42.5 g in 1 TUBE; Type 0: Not a Combination Product	09/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/25/2020

Labeler - Cross Brands Contract Filling (117871824)

Establishment
Name	Address	ID/FEI	Business Operations
Cross Brands Contract Filling		117871824	label(73440-2154) , manufacture(73440-2154) , pack(73440-2154)