HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate, oxybenzone lotion

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

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Active ingredient:
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Available from:
Jafra Cosmetics International Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
68828-118-01, 68828-118-02

HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate,

octisalate, 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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Day Care Broad Spectrum SPF 15

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 4% Sunscreen

Oxybenzone 2% Sunscreen

Uses

helps prevent sunburn

If used as directed with other sun 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. If product is swallowed, get medical help or contact a Poison Control

Center right away.

Stop use and ask a doctor if rash occurs

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.

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every two 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

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-sleeve shirts, pants, hats, and sunglasses

Water/Aqua, Polyglyceryl-3 Methylglucose Distearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,

Glyceryl Stearate, Glycerin, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol,

Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somniferia (Winter Cherry) Extract,

Vigna Radiata (Mung Bean) Extract, Trisodium EDTA, Panthenol, Tocopheryl Acetate, PEG-4 Laurate,

Iodopropynyl Butylcarbamate, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract,

Chamomilla Recutita (Matricaria) Extract(MATRICARIA RECUTITA), Morus Alba Extract, Lonicera

Caprifolium (Honeysuckle) Flower Extract, Potassium Sorbate, Fragrance/Parfum

Three Step Hand Care

Day Care Broad Spectrum SPF 15 with intellishield

Jafra

Cont. Net. 75 ml 2.5 fl oz (US)

HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA

avobenzone, octinoxate, octisalate, oxybenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 8 28 -118

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

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

OCTINOXATE

7.5 g in 10 0 mL

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

OCTISALATE

4 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

WATER (UNII: 0 59 QF0 KO0 R)

PO LYACRYLAMIDE ( 150 0 MW) (UNII: 5D6 TC4BRWV)

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

GLYCERIN (UNII: PDC6 A3C0 OX)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

HEXYLENE GLYCO L (UNII: KEH0 A3F75J)

MUNG BEAN (UNII: 1LIB31N73G)

EDETATE TRISO DIUM (UNII: 420 IP9 21MB)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

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

PEG-4 LAURATE (UNII: AYF4VM3N1Z)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

CHO NDRUS CRISPUS (UNII: OQS23HUA1X)

LO NICERA CAPRIFO LIUM FLO WER (UNII: 5N1WD9 78 4U)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 8 28 -118 -0 2

1 in 1 BOX

10 /26 /20 12

1

NDC:6 8 8 28 -118 -0 1

75 mL in 1 PACKAGE; 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 no t final

pa rt352

10 /26 /20 12

Jafra Cosmetics International Inc

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, S.A. de C.V.

8 147320 6 1

ma nufa c ture (6 8 8 28 -118 )

Revised: 5/2019

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