ESSENTIAL SHOCKEYE AND LIP- avobenzone, homosalate, octinocate, octocrylene, oxybenzone cream
Natura Bisse International, S.A.
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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Essential Shock Eye and Lip
- Avobenzone (Butyl Methoxydibenzoymethane) 3 percent.
- Homosalate 10 percent.
- Octinoxate (Ethylhexyl Methoxycinnamate) 4 percent.
- Octocrylene 2.5 percent.
- Oxybenzone (Benzophenone-3) 1 percent.
Water. Glycerin. Polyglyceryl-2 Dipolyhydroxystearate. Dimethicone. Beeswax (cera Alba). Polyglyceryl-4 Isostearate. Cetearyl Ethylhexanoate. Butylene Glycol. C12-15 Alkyl Benzoate. Rosa Canina Fruit Oil. Benxotriazolil Dodecil. Hydrolyzed Collagen. Silybum Marianum Extract. Iris Florentina Root Extract. Ananas Saticus (Pineapple) Fruit Extract. Glycine Soja (Soybean) Germ Extract. Triticum Vulgare (Wheat) Germ Extract. Proppylene Glycol. PEG-60 Hydrogenated Castor Oil. Alcohol Denat. Epsom Salt (Magnesium Sufate. Retinol. Tocopheryl Acetate. Ascorbyl Palmitate. Disodium Edta. BHT. Phynoxyethanol. Methylparaben. Ethylparaben. Butylparaben. Propylparaben. Isobutylparaben. Fragrance (Parfum). Yellow 5 (CI 19140).
- Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection
- Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Moderate sun protection product.
- Natura Bisse
- Barcelona
- Essential Shock Eye and Lip Treatment
- Nourishing eye and lip firming cream with sunscreen
- Net wt. 0.5 oz. 15 ml.
- This product can be sold only by authorized Natura Bisse retailers
- Made in Spain by
- Natura Bisse Int. S.A.
- Cerdanyola - 08290 Barcelina
- C.P. 11590 Mexico, D.F. RFC NBI0402132P0
- Not tested on animals
ESSENTIAL SHOCKEYE AND LIP
avobenzone, homosalate, octinocate, octocrylene, oxybenzone cream |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 63730-395 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) | AVOBENZONE | 454 mg in 15 mL |
| HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) | HOMOSALATE | 1.44 mg in 15 mL |
| OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) | OCTINOXATE | 0.6 mg in 15 mL |
| OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) | OCTOCRYLENE | 0.36 mg in 15 mL |
| OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) | OXYBENZONE | 151 mg in 15 mL |
|
|
|
| Product Characteristics |
| Color | yellow (FD&C YELLOW NO. 5) | Score | |
| Shape | | Size | |
| Flavor | | Imprint Code | |
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 63730-395-01 | 15 mL in 1 TUBE; Type 0: Not a Combination Product | 03/08/2017 | |
| 2 | NDC: 63730-395-02 | 1.5 mL in 1 TUBE; Type 0: Not a Combination Product | 03/08/2017 | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part352 | 03/08/2017 | 06/15/2019 |
|
| Labeler - Natura Bisse International, S.A.
(464431576)
|
| Registrant - Natura Bisse International, S.A. (464431576) |
| Establishment |
| Name | Address | ID/FEI | Business Operations |
| 464431576 | | 464431576 | manufacture(63730-395) |
