LAND SHARK PUPS SPF 50- octocrylene, octisalate, and avobenzone lotion

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

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Active ingredient:
Octocrylene 10.0%, Octisalate 5.0%, Avobenzone 3.0%
Available from:
Tropical Seas, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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
Authorization status:
OTC monograph not final
Authorization number:
52854-955-01

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LAND SHARK PUPS SPF 50- octocrylene, octisalate, and avobenzone lotion

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

Octocrylene 10.0%

Octisalate 5.0%

Avobenzone 3.0%

Purpos e

Sunscreen

Us es

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

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

apply liberally 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 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

aqueous extracts of: aloe barbadensis leaf extract, algae extract (hawaiian seaplant), chamomilla recutita

aqueous extracts of: aloe barbadensis leaf extract, algae extract (hawaiian seaplant), chamomilla recutita

(matricaria) flower extract, symphytum officinale (comfrey) root & leaf extract, taraxacum officinale

(dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower

extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula

angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis

(marshmallow) root extract, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea)

extract, phenethyl benzoate, octyl dodecyl citrate crosspolymer, stearic acid, glyceryl stearate se, cetyl

dimethicone, glycerin, sodium hydroxide, emulsifying wax, tricontanyl-pvp, polyethylene,

acrylates/c10-30 alkyl acrylates cross-polymer, cetyl alcohol, methylparaben, diazolidinyl urea,

propylparaben, and caprylyl glycol.

Other Information

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

Questions or comments?

Call toll free 1-800-368-7327

Principal Display Panel

192 ml NDC: 52854-955-01

LAND SHARK PUPS SPF 50

octocrylene, octisalate, and avobenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:528 54-9 55

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

10 g in 10 0 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

5 g in 10 0 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

3 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CARRAGEENAN (UNII: 5C6 9 YCD2YJ)

CHAMO MILE (UNII: FGL36 8 5T2X)

SYMPHYTUM UPLANDICUM LEAF (UNII: D0 5HXK6 R3G)

CO MFREY RO O T (UNII: M9 VVZ0 8 EKQ)

TARAXACUM O FFICINALE LEAF (UNII: 0 0 22LFJ74Y)

ECHINACEA, UNSPECIFIED (UNII: 4N9 P6 CC1DX)

SAMBUCUS NIGRA FLO WER (UNII: 0 7V4DX0 9 4T)

AMERICAN GINSENG (UNII: 8 W75VCV53Q)

MACRO CYSTIS PYRIFERA (UNII: K31S3OG5C4)

LAVANDULA ANGUSTIFO LIA FLO WERING TO P (UNII: 9 YT4B71U8 P)

CYMBO PO GO N SCHO ENANTHUS TO P (UNII: 9 SJI1LW39 W)

ALTHAEA O FFICINALIS RO O T (UNII: TRW2FUF47H)

ACHILLEA MILLEFO LIUM FLO WER (UNII: YQR8 R0 SQEA)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

PHENETHYL BENZO ATE (UNII: 0 C1439 29 GK)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I)

CETYL DIMETHICO NE 150 (UNII: 5L6 9 4Y0 T22)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

TRICO NTANYL PO VIDO NE (UNII: N0 SS3Q238 D)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

CARBO MER CO PO LYMER TYPE B ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 8 0 9 Y72KV36 )

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Tropical Seas, Inc.

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:528 54-9 55-

19 2 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/14/20 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 2/14/20 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 55)

Revised: 11/2020

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