SPF 50- sunscreen cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ETHYL METHOXYCINNAMATE (UNII: SD418S06XD) (ETHYL METHOXYCINNAMATE - UNII:SD418S06XD), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS)
Available from:
FRIDDA DORSCH SL
Administration route:
CUTANEOUS
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
72597-1945-0

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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.

----------

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

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7259 7-19 45

Route of Administration

CUTANEOUS, TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ETHYL METHO XYCINNAMATE (UNII: SD418 S0 6 XD) (ETHYL METHOXYCINNAMATE

- UNII:SD418 S0 6 XD)

ETHYL

METHOXYCINNAMATE

4 mg

in 50 0 0 0 mg

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

2.5 mg

in 50 0 0 0 mg

ETHYLHEXYL TRIAZO NE (UNII: XQN8 R9 SAK4) (ETHYLHEXYL TRIAZONE -

UNII:XQN8 R9 SAK4)

ETHYLHEXYL

TRIAZONE

0 .25 mg

in 50 0 0 0 mg

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

1.5 mg

in 50 0 0 0 mg

BISO CTRIZO LE (UNII: 8 NT8 50 T0 YS) (BISOCTRIZOLE - UNII:8 NT8 50 T0 YS)

BISOCTRIZOLE

3.75 mg

in 50 0 0 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PHYTATE SO DIUM (UNII: 8 8 49 6 G1ERL)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

DIBUTYL ADIPATE (UNII: F4K10 0 DXP3)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

ALANINE (UNII: OF5P57N2ZX)

CREATINE (UNII: MU728 12GK0 )

DIETHYLAMINO HYDRO XYBENZO YL HEXYL BENZO ATE (UNII: ANQ8 70 JD20 )

DEHYDRO ACETIC ACID (UNII: 2KAG279 R6 R)

PRO PYL GALLATE (UNII: 8 D4SNN7V9 2)

TRIBEHENIN PEG-2 0 ESTERS (UNII: 8 4K9 EH29 Y9 )

ALLANTO IN (UNII: 344S277G0 Z)

BIO SACCHARIDE GUM-4 (UNII: 9 XRL0 57X9 0 )

WATER (UNII: 0 59 QF0 KO0 R)

FAGUS SYLVATICA FLO WER BUD (UNII: 6 D5V130 45W)

XANTHAN GUM (UNII: TTV12P4NEE)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6 M2JG9 )

HYDRO LYZED SO Y PRO TEIN ( ENZYMATIC; 2 0 0 0 MW) (UNII: 139 4NXB9 L6 )

GLYCINE (UNII: TE76 6 0 XO1C)

PO TASSIUM MAGNESIUM ASPARTATE (UNII: 55TUI7Q42I)

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

DECYL GLUCO SIDE (UNII: Z17H9 7EA6 Y)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

PEG-4 0 CASTO R O IL (UNII: 4ERD20 76 EF)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Marketing End

FRIDDA DORSCH SL

#

Item Code

Package Description

Date

Date

1

NDC:7259 7-

19 45-0

50 0 0 0 mg in 1 TUBE, WITH APPLICATOR; Type 0 : No t a

Co mbinatio n Pro duct

11/20 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

11/20 /20 20

Labeler -

FRIDDA DORSCH SL (474018686)

Registrant -

FRIDDA DORSCH SL (474018686)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

FRIDDA DORSCH

4740 18 6 8 6

ma nufa c ture (7259 7-19 45)

Revised: 10/2020

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