COVER ME SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion 
Jafra Cosmetics International

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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Cover Me Sunscreen SPF 30

Active ingredients Purpose
Avobenzone 3%................Sunscreen
Homosalate 10%...............Sunscreen
Octisalate 5%....................Sunscreen
Octocrylene 7%.................Sunscreen

Uses

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:

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:

Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia sinensis Leaf Extract, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Maltodextrin, PEG-100 Stearate, PEG-40 Hydrogenated Castor Oil, Phenethyl Alcohol, Phenoxyethanol, Royal Jelly Powder, Royal Jelly, Silica, Styrene/Acrylates Copolymer, Tetrapeptide-45, Trideceth-9, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Zingiber Officinale (Ginger) Root Extract.

Jafra Royal Boost

Cover Me Sunscreen Broad Spectrum SPF 30

Carton

COVER ME SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-280
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) HOMOSALATE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
SHEA BUTTER (UNII: K49155WL9Y)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LEVOMENOL (UNII: 24WE03BX2T)  
ARGININE (UNII: 94ZLA3W45F)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
ROYAL JELLY (UNII: L497I37F0C)  
TRIDECETH-9 (UNII: X9HD79I514)  
COCOA (UNII: D9108TZ9KG)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAUROYL LYSINE (UNII: 113171Q70B)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ALLANTOIN (UNII: 344S277G0Z)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GINGER (UNII: C5529G5JPQ)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-280-0150 mL in 1 TUBE; Type 0: Not a Combination Product06/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/12/2018
Labeler - Jafra Cosmetics International (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-280)

Revised: 6/2020
Document Id: a7d2fd19-c425-e9c1-e053-2995a90a21d4
Set id: 6e786af5-28aa-5cf5-e053-2991aa0a3700
Version: 3
Effective Time: 20200611
 
Jafra Cosmetics International