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.

----------

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

box art

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MUNG BEAN (UNII: 1LIB31N73G)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-118-021 in 1 BOX10/26/2012
1NDC:68828-118-0175 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/26/2012
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-118)

Revised: 5/2019
Document Id: 7989a19d-8a58-4fae-a0f7-6a2152a2266c
Set id: 8d459718-20a0-494e-ba2d-b533c95bbd49
Version: 5
Effective Time: 20190522
 
Jafra Cosmetics International Inc