LAND SHARK SPF 8- octinoxate and oxybenzone oil

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate 5.0%, Oxybenzone 2.0%
Available from:
Tropical Seas, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
52854-928-01

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LAND SHARK SPF 8- octinoxate and oxybenzone oil

Tropical Seas, Inc.

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.

----------

Drug Facts

Active Ingredients

Octinoxate 5.0%

Oxybenzone 2.0%

Purpos e

Sunscreen

Us es

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin

aging. This product has been shown to prevent sunburn, not skin cancer or early skin aging.

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

apply liberally 15 minutes before sun exposure

reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

children under 6 months: Ask a doctor

Inactive Ingredients

mineral oil, ethylhexyl palmitate, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) oil,

theobroma cacao (cocoa) seed butter, fragrance, and propylparaben.

Other Information

hold apprximately 10 - 12 inches from skin to spray

spray into palm of hand, rub together, then apply to your face

do not spray directly into your face so that it won't get in your eyes.

rub into skin evenly to ensure appropriate coverage

this product provides minimum sunburn protection

fair skin types should use a higher spf

protect this product from excessive cold, heat, and direct sun

Questions or comments?

Call toll free 1-800-368-7327

Principal Display Panel - Bottle Label

250 ml NDC: 52854-928-01

LAND SHARK SPF 8

octinoxate and oxybenzone oil

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:528 54-9 28

Route of Administration

TOPICAL

Tropical Seas, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

5 g in 10 0 mL

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

2 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

MINERAL O IL (UNII: T5L8 T28 FGP)

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

JO JO BA O IL (UNII: 724GKU717M)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

CO CO A BUTTER (UNII: 512OYT1CRR)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:528 54-9 28 -

250 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/22/20 20

Marketing Information

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

pa rt352

0 7/22/20 20

Labeler -

T ropical Seas, Inc. (627865660)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Tro pical Seas, Inc.

6 278 6 56 6 0

ma nufa c ture (528 54-9 28 )

Revised: 12/2020

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