GUINOT ULTRA UV SUNSCREEN HIGH PROTECTION SUN CREAM FOR THE FACE AND BODY SPF 30 avobenzone homosalate octisalate octocrylene

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

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Active ingredient:
Avobenzone 3.0 %, Homosalate 15.0 %, Octisalate 5.0 %, Octocrylene 2.8
Available from:
GUINOT SAS
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

GUINOT ULTRA UV SUNSCREEN HIGH PROTECTION SUN CREAM FOR THE FACE

AND BODY SPF 30- avobenzone, homosalate, octisalate, octocrylene cream

GUINOT SAS

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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GUINOT Ultra UV Sunscreen High Protection Sun Cream for the face and body SPF 30

GUINOT Ultra UV Sunscreen High Protection sun cream for the face and body SPF 30

Active Ingredients

Avobenzone 3.0 %

Homosalate 15.0 %

Octisalate 5.0 %

Octocrylene 2.8

Purpos e

Sunscreen

Us es

Helps prevent sunburn

if used as directed with other sun protection measure (see Directions), decreases 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

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 is 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, regularlyuse a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alpha-Isomethyl Ionone, Betaine, Butylene Glycol,

Capryloyl Glycine, Caprylyl Methicone, Copper Gluconate, Diethylhexyl 2,6-Naphthalate,

Dimethicone, Dimethiconol, Ethylhexylglycerin, Fragrance (Parfum), Glycerin, Glyceryl

Acrylate/Acrylic Acid Copolymer, Hydrogenated Coco-Glycerides, Hydrolyzed Enteromorpha

Compressa, Limonene, Methylisothiazolinone, Oleic Acid, Oleoyl Tyrosine, Pectin, Pentaerythrityl

Distearate, Pentylene Glycol, Potassium Cetyl Phosphate, Propylene Glycol, Sodium Hyaluronate,

Sucrose, Talc, Tapioca Starch, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolamine, Water/Eau

(Aqua), Xanthan Gum.

Ref 0514520

Guinot, 1 rue de la Paix, 75002 Paris

Made in France-77190 Dammarie

Guinot Institut Paris

Ultra UV Sunscreen High Protection Sun Cream for the Face

30 FPS UVA/UVB SPF

High Protection

Broad Spectrum

e 50 ml NET WT 1.6 OZ

Guinot Ultra UV Sunscreen High Protection Sun Cream For the Face SPF 30 50 ml

GUINOT ULTRA UV SUNSCREEN HIGH PROTECTION SUN CREAM FOR THE

FACE AND BODY SPF 30

avobenzone, homosalate, octisalate, octocrylene cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5418 1-0 0 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

AVOBENZONE

3 mg in 1 mL

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

15 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

5 mg in 1 mL

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

OCTOCRYLENE

2.8 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

PENTAERYTHRITYL DISTEARATE (UNII: 6 9 7WOT8 HNB)

CAPRYLYL TRISILO XANE (UNII: Q9 5M2P1KJL)

PENTYLENE GLYCO L (UNII: 50 C130 7PZG)

PO TASSIUM CETYL PHO SPHATE (UNII: 0 3KCY6 P7UT)

DIETHYLHEXYL 2 ,6 -NAPHTHALATE (UNII: I0 DQJ7YGXM)

TALC (UNII: 7SEV7J4R1U)

STARCH, TAPIO CA (UNII: 24SC3U70 4I)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

HYDRO GENATED CO CO -GLYCERIDES (UNII: XDD37N2GPR)

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

XANTHAN GUM (UNII: TTV12P4NEE)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

BETAINE (UNII: 3SCV18 0 C9 W)

ULVA CO MPRESSA PRO TEIN ( ACID HYDRO LYZED, 3 0 0 -50 0 0 MW) (UNII: Q0 4O53779 D)

PECTIN (UNII: 8 9 NA0 2M4RX)

SUCRO SE (UNII: C151H8 M554)

O LEO YL TYRO SINE (UNII: 131P1BQX1U)

CAPRYLO YL GLYCINE (UNII: 8 TY5YO42NJ)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

O LEIC ACID (UNII: 2UMI9 U37CP)

CO PPER GLUCO NATE (UNII: RV8 23G6 G6 7)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

GUINOT SAS

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5418 1-0 0 3-50

1 in 1 PACKAGE

1

50 mL in 1 TUBE

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

0 1/0 2/20 14

Labeler -

GUINOT SAS (763667185)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GUINOT SAS

76 36 6 718 5

ma nufa c ture (5418 1-0 0 3)

Revised: 11/2013

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