SHIPS AHOY SEASHORE SUNSCREEN BROAD SPECTRUM SPF 30 JAFRA- avobenzone, homosalate,octisalate, octocrylene, oxybenzone lotion

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

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Active ingredient:
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Available from:
Jafra Cosmetics International Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final
Authorization number:
68828-186-01, 68828-186-02

SHIPS AHOY SEASHORE SUNSCREEN BROAD SPECTRUM SPF 30 JAFRA- avobenzone,

homosalate,octisalate, octocrylene, oxybenzone lotion

Jafra Cosmetics International 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.

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Ships Ahoy Seashore Sunscreen SPF 30

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 7.5% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 2.79 Sunscreen

Oxybenzone 4% Sunscreen

Uses

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.

Keep out of reach of children

Stop use and ask a doctor if rash occurs

Warnings

For External use only

Do not use on damaged skin

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply 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 this risk,

regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection

measures including:

-limit time in the sun, especially from 10 a.m. - 2p.m.

-wear long-sleeve shirts, pants, hats, and sun glasses

Water/Aqua, Glyceryl Stearate, Octyldodecyl Neopentanoate, Polyester-8, Adipic Acid/Diglycol

Crosspoymer, Potassium Cetyl Phosphate, Glycerin, Tricontanyl PVP, Caprylyl Glycol, Hexylene

Glycol, Methylisothiazolinone, Bisabolol, Cetyl Dimethicone, Tocopheryl Acetate, Dimethicone,

Xanthan Gum, Allantoin, Trisodium EDTA, Blue 1/CI 42090, Green 5/CI 61570, Ethylhexylglycerin

Jafra Ships Ahoy

Seashore Sunscreen SPF 30

Sunscreen Broad Spectrum SPF 30

50ml 1.7 Fl Oz

SHIPS AHOY SEASHORE SUNSCREEN BROAD SPECTRUM SPF 30 JAFRA

avobenzone, homosalate,octisalate, octocrylene, oxybenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 8 28 -18 6

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

AVOBENZONE

3 g in 10 0 mL

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

7.5 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

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

OCTOCRYLENE

2.79 g in 10 0 mL

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

OXYBENZONE

4 g in 10 0 mL

Jafra Cosmetics International Inc

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

O CTYLDO DECYL NEO PENTANO ATE (UNII: X8 725R8 8 3T)

PO LYESTER-8 ( 14 0 0 MW, CYANO DIPHENYLPRO PENO YL CAPPED) (UNII: T9 29 6 U138 P)

ADIPIC ACID (UNII: 76 A0 JE0 FKJ)

PO TASSIUM CETYL PHO SPHATE (UNII: 0 3KCY6 P7UT)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

HEXYLENE GLYCO L (UNII: KEH0 A3F75J)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

LEVO MENO L (UNII: 24WE0 3BX2T)

CETYL DIMETHICO NE 4 5 (UNII: IK315POC44)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

XANTHAN GUM (UNII: TTV12P4NEE)

ALLANTO IN (UNII: 344S277G0 Z)

EDETATE TRISO DIUM (UNII: 420 IP9 21MB)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

D&C GREEN NO . 5 (UNII: 8 J6 RDU8 L9 X)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 8 28 -18 6 -0 2

1 in 1 CARTON

0 2/24/20 14

1

NDC:6 8 8 28 -18 6 -0 1

50 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 2/24/20 14

Labeler -

Jafra Cosmetics International Inc (041676479)

Registrant -

Jafra Cosmetics International Inc (041676479)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Jafra Manufacturing

8 147320 6 1

ma nufa c ture (6 8 8 28 -18 6 )

Revised: 5/2019

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