Sunscreen Cream SPF 30

Drug Labeling and Warnings

Drug Details [pdf]

SUNSCREEN SPF 30 JAFRA- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream 
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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Sunscreen Cream SPF 30

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

Kee out 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

apply liberally 15 minutes before sun exposure

reapply at least ever 2 hours, especially if swimming, sweating, or after toweling

use a water resistant sunscreen if swimming or sweating

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 SPF 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

Adipic Acid/Diglycol Crosspolymer, Allantoin, Bisabolol, Caprylyl Glycol, Cetyl Dimethicone, Dimethicone, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hexylene Glycol, Methylisothiozolinone, Octyldodecyl Neopentanoate, Polyester-8, Potassium Cetyl Phosphate, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water/Aqua, Xanthan Gum.

carton back

carton front

Jafra Sun

Sunscreen Cream SPF 30

UVA/UVB protection

Cont. Net. 125 ml 4 Fl. Oz

SUNSCREEN SPF 30  JAFRA
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68828-162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.79 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
LEVOMENOL (UNII: 24WE03BX2T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68828-162-021 in 1 CARTON12/04/201211/27/2018
1NDC: 68828-162-01125 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/04/201211/27/2018
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-162)

Revised: 5/2019
 
Jafra Cosmetics International Inc