Dr.denese Spf 30 Defense Day Cream

Dr.denese Spf 30 Defense Day Cream
SPL v7
SPL
SPL Set ID 511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa
Route
TOPICAL
Published
Effective Date 2011-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (7.5 g) Octinoxate
Inactive Ingredients
Silicon Dioxide Glycerin Isododecane Propylene Glycol Imidurea Phenoxyethanol Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Cyclomethicone Water Dimethicone Glyceryl Dibehenate Alkyl (c12-15) Benzoate Aloe Vera Leaf Talc Octyldodecyl Neopentanoate Butylene Glycol Phytonadione Vitamin A Palmitate Ascorbic Acid Ascorbyl Palmitate .beta.-sitosterol Niacin Thiamine Mononitrate Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-05-21

Description

Active Ingredients                                                     Purpose Zinc Oxide 7.5%                                                   Sunscreen Octinoxate 7.5% (Ethyl Hexyl Methoxycinnamate)   Sunscreen


Medication Information

Warnings and Precautions

Warnings  For external use only

Dosage and Administration

Directions  - Apply liberally to sun exposed areas 30 minutes before sun exposure or as needed.  - Children under 6 months : Consult physician. - Reapply as needed. Reapply before extended sun exposure, after swimming, towel drying, or sweating.

Description

Made in USA  SkinScience Labs Inc.  Ridgefield, NJ 07657  www.drdenese.com

Use

Helps prevent sunburn. Higher SPF gives more sun protection.

Section 42232-9

Other information  - Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Section 50565-1

Keep out of reach of children.

Section 50566-9

- If redness and irritation develops and persists discontinue use and consult a physician.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 51727-6

Inactive ingredients Cyclomethicone, Aqua (Water), Dimethicone, Polysilicone II, Glyceryl Behenate, C12-15 Alkyl Benzoate, Aloe Barbadensis Leaf Extract, Talc, Butyl Methoxydibenzolmethane, Octyldodecyl Neopentanoate, DEA Oleth-3 Phosphate, Cetyl Dimethicone Copolyol, PEG/PPG-18/18 Dimethicone, Melanine, Hydrogenated Lecithin, Butylene Glycol, Phytonadione (Vit K), Retinyl Palmitate (Vit A), Tocopheryl Acetate (Vit E), Ascorbic Acid, Ascorbyl Palmitate (Vit C), Beta Sitosterol, Niacin (Vit B3), Calcium Panthotenate (Vit B 5), Pyridoxine HCI (Vit B 6), Thiamine Nitrate (Vit B 1), Polysorbate 80, Nylon 12, Silica, Polyglyceryl-6 Octa Stearte, Glycerin, Isododecane, Propylene Glycol, Imidazolidinyl Urea, Phenoxyethanol May Contain: Iron Oxides ( CI 77491, CI 77492, CI 77499).





Section 51945-4

DR. DENESE NEW YORK  SPF 30 Defense Day Cream  Broad Spectrum UVA/UVB - Matte Finish  Tinted - Oil Free Zinc-Oxide Based  4 oz (120 g)

Section 55105-1

Uses  - Helps prevent sunburn  - Higher SPF provides more protection.

Section 55106-9

Active Ingredients                                                     Purpose Zinc Oxide 7.5%                                                   Sunscreen Octinoxate 7.5% (Ethyl Hexyl Methoxycinnamate)   Sunscreen



Section 60561-8

In case of accidental ingestion seek medical assistance or contact Poison Control Center immediately.


Structured Label Content

Use

Helps prevent sunburn. Higher SPF gives more sun protection.

Dosage and Administration (34068-7)

Directions  - Apply liberally to sun exposed areas 30 minutes before sun exposure or as needed.  - Children under 6 months : Consult physician. - Reapply as needed. Reapply before extended sun exposure, after swimming, towel drying, or sweating.

Warnings and Precautions (34071-1)

Warnings  For external use only

Description (34089-3)

Made in USA  SkinScience Labs Inc.  Ridgefield, NJ 07657  www.drdenese.com

Section 42232-9 (42232-9)

Other information  - Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

- If redness and irritation develops and persists discontinue use and consult a physician.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 51727-6 (51727-6)

Inactive ingredients Cyclomethicone, Aqua (Water), Dimethicone, Polysilicone II, Glyceryl Behenate, C12-15 Alkyl Benzoate, Aloe Barbadensis Leaf Extract, Talc, Butyl Methoxydibenzolmethane, Octyldodecyl Neopentanoate, DEA Oleth-3 Phosphate, Cetyl Dimethicone Copolyol, PEG/PPG-18/18 Dimethicone, Melanine, Hydrogenated Lecithin, Butylene Glycol, Phytonadione (Vit K), Retinyl Palmitate (Vit A), Tocopheryl Acetate (Vit E), Ascorbic Acid, Ascorbyl Palmitate (Vit C), Beta Sitosterol, Niacin (Vit B3), Calcium Panthotenate (Vit B 5), Pyridoxine HCI (Vit B 6), Thiamine Nitrate (Vit B 1), Polysorbate 80, Nylon 12, Silica, Polyglyceryl-6 Octa Stearte, Glycerin, Isododecane, Propylene Glycol, Imidazolidinyl Urea, Phenoxyethanol May Contain: Iron Oxides ( CI 77491, CI 77492, CI 77499).





Section 51945-4 (51945-4)

DR. DENESE NEW YORK  SPF 30 Defense Day Cream  Broad Spectrum UVA/UVB - Matte Finish  Tinted - Oil Free Zinc-Oxide Based  4 oz (120 g)

Section 55105-1 (55105-1)

Uses  - Helps prevent sunburn  - Higher SPF provides more protection.

Section 55106-9 (55106-9)

Active Ingredients                                                     Purpose Zinc Oxide 7.5%                                                   Sunscreen Octinoxate 7.5% (Ethyl Hexyl Methoxycinnamate)   Sunscreen



Section 60561-8 (60561-8)

In case of accidental ingestion seek medical assistance or contact Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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