FACE AND BODY SPF 15- octinoxate, oxybenzone, avobenzone cream

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

Buy It Now

Active ingredient:
Octinoxate, Oxybenzone, Avobenzone
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 Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Authorization status:
OTC monograph final
Authorization number:
73310-1522-3

FACE AND BODY SPF 15- octinoxate, oxybenzone, avobenzone 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.

----------

AGESKIN Sunscreen SPF 15 Face and Body

ACTIVE INGREDIENTS

Octinoxate

Oxybenzone

Avobenzone

PURPOSE

Sunscreen

USES

Helps prevent sunburn

Use as directed with other sun protection measures (see Directions), decreases the risk of skin cancer

and early skin aging caused by the sun

WARNING

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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

Center right away.

DIRECTIONS

Apply liberally, 15 minutes before sun exposure

Reapply: at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

SUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early

skin aging.

To decrease this risk,regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and

other sun protection measures including:

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

Wear long-sleaved shirts, pants, hats, and sunglusses

Children under 6 months. Ask a doctor

INACTIVE INGREDIENTS

water, C12-15 alkyl benzoate, disopropyl sebacate, isononyl isononanoate, squalane, glyceril stearate,

cocos nucifera oil, cetearyl alcohol, propylene glycol, peg-100 stearate, glycerin, dimethicone,

vp/eicosene copolymer, calendula officinalis flower extract, ammonium acryloyldimethyltaurate,

vp/copolymer, bixia orellana seed extract, hydrolyzed wheat protein, hydrolyzed soy protein,

tocopherol, tocopheryl acetate, tripeptide-10 citrulline, caprylic/capric triglyceride, xanthan gum,

pseudoalteromonas ferment extract, tripeptide-1, lecithin, carbomer, triethanolamine, benzyl alcohol,

dimethiconol behenate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, diethylhexyl

syringylidenemalonate, parfum, hexyl cinnamal, coumarin, limonene, linalool, citronellol, menthyl

lactate, ethylhexylglycerin, polysorbate 60

STORAGE

Protect this container from heat and sun

SUNSCREEN LABEL

SCREEN 1510 SPF 15

FACE AND BODY SPF 15

octinoxate, oxybenzone, avobenzone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73310 -1522

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

Inactive Ingredients

Ingredient Name

Stre ng th

ISO NO NYL ISO NO NANO ATE (UNII: S4V5BS6 GCX)

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 -1522-

150 mL in 1 BOTTLE, PLASTIC; 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 -1522)

Revised: 9/2019

Similar products

Search alerts related to this product

View documents history

Share this information