SPF 50 by FRIDDA DORSCH SL / FRIDDA DORSCH OTC

SPF 50 by

Drug Labeling and Warnings

SPF 50 by is a Otc medication manufactured, distributed, or labeled by FRIDDA DORSCH SL, FRIDDA DORSCH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPF 50- sunscreen cream 
FRIDDA DORSCH SL

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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OTC

SPF 50
Antiaging Photoprotector
Moisturizer with very High Protection
Transparent and Matt looking

Anti-aging Moisturizer with Biological Sunsscreen for all skin types

Moisturizing, light, matt and fluid cream providing skin protection against sun exposure, thereby protecting the skin DNA. With sunscreens, soothing anti-inflammatory plant ingredients (organic chamomile and bisabolol), tripeptide- 33, Natural Moisturizing Factor components and epithelial growth factors.

Protects the skin from exposure to sunlight at 3 levels:

1 Epidermis: protects against sunburn and erythema caused by UVB radiation

2 Dermal: protects against pigmentation damage or dark spots caused by UVA radiation

3 Cellular: protects the DNA and cells by neutralizing the damaging effects of free radical

Inmediate and long-lasting action.

Instructions for use: Suitable for all skin types, including those most sensitive to sunlight, prone to spotting and/or skins that have undergone laser therapy or radiotherapy.

SPF 50 UVA
Antiaging Photoprotector
Moisturizer with very High Protection

Anti-aging Moisturizer with Biological Sunsscreen for all skin types

Moisturizing, light, matt and fluid cream providing skin protection against sun exposure, thereby protecting the skin DNA. With sunscreens, soothing anti-inflammatory plant ingredients (organic chamomile and bisabolol), tripeptide- 33, Natural Moisturizing Factor components and epithelial growth factors.

Protects the skin from exposure to sunlight at 3 levels:

1 Epidermis: protects against sunburn and erythema caused by UVB radiation

2 Dermal: protects against pigmentation damage or dark spots caused by UVA radiation

3 Cellular: protects the DNA and cells by neutralizing the damaging effects of free radical

Inmediate and long-lasting action.

Instructions for use: Suitable for all skin types, including those most sensitive to sunlight, prone to spotting and/or skins that have undergone laser therapy or radiotherapy.

SPF 50 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72597-1945
Route of Administration	CUTANEOUS, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ETHYL METHOXYCINNAMATE (UNII: SD418S06XD) (ETHYL METHOXYCINNAMATE - UNII:SD418S06XD)	ETHYL METHOXYCINNAMATE	4 mg  in 50000 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 mg  in 50000 mg
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	0.25 mg  in 50000 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.5 mg  in 50000 mg
BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS)	BISOCTRIZOLE	3.75 mg  in 50000 mg

Inactive Ingredients
Ingredient Name	Strength
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SORBIC ACID (UNII: X045WJ989B)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
TOCOPHEROL (UNII: R0ZB2556P8)
ALANINE (UNII: OF5P57N2ZX)
CREATINE (UNII: MU72812GK0)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PROPYL GALLATE (UNII: 8D4SNN7V92)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
ALLANTOIN (UNII: 344S277G0Z)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
WATER (UNII: 059QF0KO0R)
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
GLYCINE (UNII: TE7660XO1C)
POTASSIUM MAGNESIUM ASPARTATE (UNII: 55TUI7Q42I)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72597-1945-0	50000 mg in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	11/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/20/2020	05/24/2021

Labeler - FRIDDA DORSCH SL (474018686)

Registrant - FRIDDA DORSCH SL (474018686)

Establishment
Name	Address	ID/FEI	Business Operations
FRIDDA DORSCH		474018686	manufacture(72597-1945)

Revised: 5/2021

Document Id: c351bff3-7aa0-3e04-e053-2a95a90ae1a4

34390-5

Set id: 7533ddd3-8de1-1548-e053-2a91aa0a94c3

Version: 2

Effective Time: 20210527