FACE SPF 50- avobenzone,octinoxate,octocrylene, oxybenzone, titanium dioxide cream

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

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Active ingredient:
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
AGEFARM SRL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
SUNSCREEN helps prevent sunburn use as directed with other sun protection measures (see Direction), decrease the risk of skin cancer and early skin aging caused by the sun
Authorization status:
OTC monograph final
Authorization number:
73310-5022-2

FACE SPF 50- avobenzone,octinoxate,octocrylene, oxybenzone, titanium dioxide cream

AGEFARM 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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SUNSCREEN Face SPF 50

Drug Facts

Active ingredients

AVOBENZONE 2%

OCTINOXATE 2%

OCTOCRYLENE 2%

OXYBENZONE 2%

TITANIUM DIOXIDE 2%

PURPOSE

SUNSCREEN

USES

helps prevent sunburn

use as directed with other sun protection measures (see Direction), decrease the risk of skin cancer and

early skin aging caused by the sun

WARNINGS

For external use only

Do not use on damaged or broken skin

Stop use and ask doctor if rash occurs

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

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

away.

DIRECTIONS

apply liberally 15 minutes before sun exposure

reapply: at least every 2 hours, immediately after towel drying

use a water-resistant sunscreen if swimming or sweating

children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk, regularly use a sunscreen with a

broad spectrum SPF value of 15 or higher and other sun protection measures including:

limite the time in the sun, especially from 10 a.m. - 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS

ammonium acryloydimethytaurate-vp copolymer, bis-ethylhexyloxphenol methoxphenyl triazine, BHT,

butyrospermum parkii butter extract, caprylic capric triglyceride, carbomer, carthamus, cetearyl

alcohol, citronellol,coumarin, diethylhexylsyringylidenemalonate, decyl gluside, diisopropyl sebacate,

dimethicone, dimethiconol behenate, c12-15 alkyl benzoate, glycerin, glyceryl stearate, hexyl cinnamal,

hydrolyzed soy protein, hydrolyzed wheat protein, limanathes alba seed oil, limonene, linalool,

methylene bisbenzotriazolyl tetramethybutyphenol (nano), menthyl lactate, methylisothiazolinone, olea

europapea oil unasonifiables, parfum, peg-100 stearate, phenoxyethanol, pseudoalteromonas ferment

extract, propylene glycol, tocopherylacetate, triethanolamine, tripeptide-1, tripeptide-10 citrulline, vp-

eicosene copolymer, water, xanthan gum

OTHER INFORMATION

Protect this product from excessive heat and direct sun

SUNSCREEN LABEL

SUNSCREEN FACE SPF 50 SPRAY 5022

FACE SPF 50

avobenzone,octinoxate,octocrylene, oxybenzone, titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73310 -50 22

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

OCTOCRYLENE

1 mg in 5 mL

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

1 mg in 5 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

1 mg in 5 mL

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

1 mg in 5 mL

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

TITANIUM DIOXIDE

1 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

1 mg in 5 mL

Product Characteristics

Color

white (Cream)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:73310 -50 22-

50 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /28 /20 19

AGEFARM SRL

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 8 /28 /20 19

Labeler -

AGEFARM SRL (439202467)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

COSMESIT SRL

339 0 719 51

ma nufa c ture (73310 -50 22)

Revised: 9/2019

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