JAFRA SUN BODY PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

Jafra Sun body protector sunscreen broad spectrum SPF 50 by

Drug Labeling and Warnings

Jafra Sun body protector sunscreen broad spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%..............Sunscreen

Homosalate 10%.............Sunscreen

Octisalate 5%..................Sunscreen

Octocrylene 10%.............Sunscreen

PURPOSE

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

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.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally and evenly 15 minutes before sun exposure
•  Reapply:
  after 40 minutes of swimming or sweating
  immediately after towel drying
  at least every 2 hours
• children under 6 months of age : 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. - 2 p.m.
        wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

• protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Polyester-8, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Ethylhexyl Methoxycrylene, Phenoxyethanol, Ethylhexylglycerin, Mica, Silica, Arginine, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance/Parfum, Disodium EDTA, Panthenol, Bisabolol, Sambucus Nigra (Elderberry) Fruit Extract, Benzyl Salicylate, Butylphenyl Methylpropional, Coumarin, Hydroxycitronellal, Linalool, Limonene

Questions?

Call 1-800-551-2345 or visit www.jafra.com

Product label

INGREDIENTS AND APPEARANCE

JAFRA SUN BODY PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-294
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
PEG-100 STEARATE (UNII: YD01N1999R)
PANTHENOL (UNII: WV9CM0O67Z)
ARGININE (UNII: 94ZLA3W45F)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
LEVOMENOL (UNII: 24WE03BX2T)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
COUMARIN (UNII: A4VZ22K1WT)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-294-01	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021
2	NDC: 68828-294-02	7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/14/2021

Labeler - Distribuidora Comercial Jafra, S.A. de C.V. (951612777)

Registrant - Jafra Cosmetics International, Inc. (031183599)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-294)