Protector Stick

Drug Labeling and Warnings

Drug Details [pdf]

PROTECTOR SPF 15 JAFRA SUN- avobenzone, homosalate, octisalate, oxybenzone stick 
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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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.

back

front

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
CANDELILLA WAX (UNII: WL0328HX19)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
BEHENYL BEHENATE (UNII: K8NU647RJ0)  
MICA (UNII: V8A1AW0880)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
ISOEICOSANE (UNII: AR294KAG3T)  
ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PCA (UNII: 29C5O2BJYA)  
SOYBEAN GERM (UNII: JBW2VHD14M)  
CERAMIDE 3 (UNII: 4370DF050B)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68828-097-011 in 1 CARTON05/15/201212/25/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/15/201212/25/2018
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-097)

Revised: 5/2019