Protector SPF 15 Jafra Sun

Dosage form: stick
Ingredients: AVOBENZONE 2.5g in 100g, HOMOSALATE 7.5g in 100g, OCTISALATE 2.0g in 100g, OXYBENZONE 5.0g in 100g
Labeler: Jafra Cosmetics International Inc
NDC Code: 68828-097

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.

Protector Stick

Active ingredients Purpose

Avobenzone 2.5% Sunscreen

Homosalate 7.5% Sunscreen

Octisalate 2% Sunscreen

Oxybenzone 5% 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. If product is swallowed, get medical help or contact a Poison Control Center.

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 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 SPF 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 sunglasses

Inactive Ingredients: Castor (Ricinus Communis) Oil, Bis-diglyceryl Polyacrylamide-2, Candellila (Euphorbia Cerifera) Wax, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Polyisobutene, C12-13 Alkyl Lactate, Synthetic Beeswax, PPG-51/SDMI Copolymer, Mica, Silica, Carnauba (Copernica Cerifera) Wax, Tri-C14-15 Alkyl Citrate, Stearalkonium Hectorite, Propylene carbonate, Microcrystaline (cera microcrystallina) Wax, Behenyl Behenate, Mica, Hydrogenated Palm Kernel Glyceride, Hydrogenated Palm Glycerides, Isoeicosane, Isopropylparaben, Isobutylparaben, Butylparaben, Tocopheryl Acetate, Tocopherol, Propylparaben, Lauryl PCA, Soybean (Glycine Soja) Extract, Ceramide III, Allantoin, Pyridoxine, Dicaprylate, Ascorbyl Palmitate, Fragrance/Parfum.

Jafra Sun 15

Protector Stick

Broad Spectrum SPF 15

Advanced UVA/UVB

Provides moisturizing SPF 15 solar protection

Con.t Net. 4g Net Net Wt .15 oz

PROTECTOR SPF 15  JAFRA SUN
avobenzone, homosalate, octisalate, oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-097
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.5 g  in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE7.5 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE2.0 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE5.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
CANDELILLA WAX 
ISOPROPYL PALMITATE 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYISOBUTYLENE (1300 MW) 
MICA 
SILICON DIOXIDE 
CARNAUBA WAX 
PROPYLENE CARBONATE 
MICROCRYSTALLINE WAX 
BEHENYL BEHENATE 
MICA 
HYDROGENATED PALM GLYCERIDES 
ISOEICOSANE 
ISOPROPYLPARABEN 
ISOBUTYLPARABEN 
BUTYLPARABEN 
.ALPHA.-TOCOPHEROL ACETATE 
TOCOPHEROL 
PROPYLPARABEN 
LAURYL PCA 
SOYBEAN GERM 
CERAMIDE 3 
ALLANTOIN 
ASCORBYL PALMITATE 
Packaging
#Item CodePackage Description
1NDC:68828-097-011 TUBE in 1 CARTON
14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/15/2012
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIOperations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-097)

Revised: 02/2013
 
Jafra Cosmetics International Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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