![FACE AND BODY SUNSCREEN SPF 35 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [JAFRA COSMETICS INTERNATIONAL]](https://medic.hrt.org//dailymed/images/84fd621d-637b-42a4-afe9-31bfccee5f96/back.jpg)
![FACE AND BODY SUNSCREEN SPF 35 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [JAFRA COSMETICS INTERNATIONAL]](https://medic.hrt.org//dailymed/images/84fd621d-637b-42a4-afe9-31bfccee5f96/front.jpg)
| NDC | 68828-166-01, 68828-166-02 |
| Set ID | 84fd621d-637b-42a4-afe9-31bfccee5f96 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | JAFRA COSMETICS INTERNATIONAL |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 2.79% Sunscreen
Oxybenzone 6% Sunscreen
CloseUses
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 swallowed, get medical help or contact a Posion 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
Apply liberally 15 minutes before sun exposure
rapply:
after 40 minutes of swimming or sweating
immediately after towel drying
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. - 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Bisabolol, Butyrospermum Parkii(Shea Butter) Fruit, Caprylyl Glycol, Cetearyl Alcohol, Cyclopentasiloxane, DMDM Hydantoin, Fragrance/parfum, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Moringa Oliefera Extract, Octyldodecyl Neopentanoate, Panthenol, Phenoxyethanol. Polyester-8, Polysorbate 20, Potassium Sorbate, Sorbitan Oleate, Thermus Thermophillus Ferment, Tocopheryl Acetate, Triethanolamine, Trisodium EDTA, Vetivera Zinzanoids (Khus Root) Extract, Water/Aqua, Withania Somniferia (Winter Cherry) Extract, Zingiber Officinale (Ginger) Extract.
- PRINCIPAL DISPLAY PANEL
Jafra SunFace and Body Sunscreen Spray
Broad Spectrum SPF 35
UVA/UVB SPF 35
Cont. Net. 125 ml 4.2 Fl Oz
Close - INGREDIENTS AND APPEARANCE
FACE AND BODY SUNSCREEN SPF 35 JAFRA
avobenzone, homosalate, octisalate, octocrylene, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-166 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.79 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) LEVOMENOL (UNII: 24WE03BX2T) SHEA BUTTER (UNII: K49155WL9Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DMDM HYDANTOIN (UNII: BYR0546TOW) GLYCERIN (UNII: PDC6A3C0OX) LICORICE (UNII: 61ZBX54883) HEXYLENE GLYCOL (UNII: KEH0A3F75J) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) EDETATE TRISODIUM (UNII: 420IP921MB) WATER (UNII: 059QF0KO0R) CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) GINGER (UNII: C5529G5JPQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-166-02 1 in 1 CARTON 01/10/2013 1 NDC:68828-166-01 125 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/10/2013 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) CloseEstablishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-166)