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Name:Biodynamic Skin
Manufacturer:S.i.p.r.e.s. Srl
Category:Over-the-counter (OTC) Marketed Drugs


Biodynamic Skin Solution

BIODYNAMIC SKIN  - avobenzone and octinoxate solution 
S.I.P.R.E.S. SRL

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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Biodynamic Skin Solution

Active ingredients                                                 Purpose

Avobenzone 3.0 %............................................ Sunscreen

Octinoxate 7.5 %...............................................Sunscreen

Uses

- helps prevent sunburn

- higher SPF gives more sunburn protection

Warnings

For external use only

When using this product

- keep out of eyes

- rinse with water to remove

- TO USE: apply each morning to a clean face and neck and after Biodynamic Skin Solution Serum. Massage in lightly until product is absorbed.

Stop use and ask a doctor if

- rash or irritation develops and lasts.

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

Directions

- apply evenly before sun exposure

- reapply as needed

- children under 6 months of age: ask a doctor

Other information

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.

Inactive ingredients: Aqua (Water), Zea Mays Oil (Corn (Zea Mays) Oil), Cetearyl Alcohol, Cetyl Alcohol, Glycerin, Peg-20 Stearate, Pyrus Communis Seed Extract (Pear (Pyrus Communis) Seed Extract), Pyrus Malus Fruit Extract (Apple (Pyrus Malus) Fruit Extract), Vitis Vinifera Seed Oil (Grape (Vitis Vinifera) Seed Oil), Oryza Sativa Germ Oil (Rice(Oryza Sativa) Germ Oil), Bifida Ferment Lysate, Ceramide 3, Bacillus Ferment, Palmitoyl Tripeptide-5, Collagen, Hexyldecanol, Propylene Glycol, Hydrolyzed Elastin, Retinol, Lactis Proteinum, Lactose, Dimethicone, Caprylic/capric Triglyceride, Triethyl Citrate, Tocopherol, Bha, Parfum (Fragrance), Imidazolidinyl Urea, Methylchloroisothiazolinone, Methylisothiazolinone.

As we age, our once youthful, healthy skin succumbs to an enzymatic imbalance that wears away the cellular network, resulting in loss of elasticity and aging. Combining the best of nature and cosmetic biotechnology, Biodynamic Skin Solution products are formulated with hydrating Enzymes that gently exfoliate and smooth the skin for a youthful glow. Benefiting from fertile orchards in the Italian countryside, Biodynamic Skin Solution formulas are rich in Phytohormones, Flavonoids and Fatty Acids from key extract in Apple and Pear Seeds, enzymatically modified and developed especially for the care if aging skin. This daytime cream helps to fortify and maintain the skin's appearance against aging and the environmental stress of everyday life.

- Probiotic ingredients from milk proteins balance and help to  protect against age and environmental aggressors.

- Peptides and Ceramides help to optimize elasticity and firmness.

- SPF 15 helps to protect against the sun and sunburn.


TO USE: apply each morning to a clean face and neck and after Biodynamic Skin Solution Serum. Massage in lightly until product is absorbed.

NO CRUELTY

RS05-TA011 - MADE IN ITALY - Distributed by:

GT PARTNERS, LLC - NEW YORK - NY 10022   12 M

Biodynamic Skin Solution

Multi-Protection Daily Renewal SPF15

Advanced Lifting Effect

Anti-Aging Complex Treatment

50 ml e                     NET WT 1.7 oz.

NO CRUELTY

12 M

This daytime cream optimizes enzymatic activity as nourishing Apple and Pear Extracts help to fortify and maintain the skin's appearance against aging and the environmental stress of everyday life. -Probiotic ingredients from milk proteins balance and help to protect against age and environmental aggressors. -Peptides and Ceramides help to optimize elasticity and firmness. -SPF 15 helps to protect against the sun and sunburn. TO USE: apply each morning to a clean face and neck and after Biodynamic Skin Solution Serum. Massage in lightly until product is absorbed. Active ingredients: Avobenzone 3.0 % - Octinoxate 7.5 %.

RS05-TA011

MADE IN ITALY - Distributed by: GT PARTNERS LLC, 300 KENNEDY DRIVE, SAYREVILLE, NJ 08872 U.S.A.

Biodynamic Skin Solution

Multi-Protection Daily Renewal SPF15

Advanced Lifting Effect

Anti-Aging Complex Treatment

50 ml e                      NET WT 1.7 oz.


Biodynamic Skin Solution

Advanced Lifting Effect

Anti-Aging Complex Treatmen

50 ml e                      NET WT 1.7 oz.

NO CRUELTY

RS05-TA011 - MADE IN ITALY -

Distributed by:

GT PARTNERS LLC, 300 KENNEDY DRIVE, SAYREVILLE, NJ 08872 U.S.A.

Biodynamic Skin Solution Inner

Biodynamic Skin Solution Outer


BIODYNAMIC SKIN 
avobenzone, octinoxate solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52371-200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
CORN OIL  
CETOSTEARYL ALCOHOL  
CETYL ALCOHOL  
GLYCERIN  
GRAPE SEED OIL  
PROPYLENE GLYCOL  
RETINOL  
LACTOSE  
DIMETHICONE  
MEDIUM-CHAIN TRIGLYCERIDES  
TRIETHYL CITRATE  
ALPHA-TOCOPHEROL  
BUTYLATED HYDROXYANISOLE  
IMIDUREA  
METHYLCHLOROISOTHIAZOLINONE  
METHYLISOTHIAZOLINONE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52371-200-50 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the BOX (52371-200-50)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/22/2010

Labeler - S.I.P.R.E.S. SRL (440712842)
Establishment
Name Address ID/FEI Operations
S.I.P.R.E.S. SRL 440712842 manufacture

Revised: 07/2010 S.I.P.R.E.S. SRL



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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