YANBAL SENTIVA EXTRACTO DIVINO YOUTH RENEWAL MOISTURIZING SPF 20- avobenzone, octisalate, octocrylene cream

YANBAL SENTIVA EXTRACTO DIVINO YOUTH RENEWAL MOISTURIZING SPF 20 by

Drug Labeling and Warnings

YANBAL SENTIVA EXTRACTO DIVINO YOUTH RENEWAL MOISTURIZING SPF 20 by is a Otc medication manufactured, distributed, or labeled by Yanbal USA, Inc., Yanbal de Columbia S.A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 2%

Octisalate 3%

Octocrylene 2%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (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 or immediately after towel drying
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use 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 am . - 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
• Report serious adverse event to Report Reaction, LLC, P.O. Box 22, Plalnsboro, NJ 08536-0222

Inactive Ingredients

AQUA/WATER, HYDROXYETHYL UREA, GLYCERIN, PHENETHYL BENZOATE, CAPRYLYL METHICONE, PROPANEDIOL, ISOSORBIDE DICAPRYLATE, POLYGLYCERYL-3 DISTEARATE, STYRENE/ACRYLATES COPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYETHYLENE, ACETYL GLUCOSAMINE, THEOBROMA CACAO (COCOA) SEED BUTTER, SODIUM ACRYLATES COPOLYMER, HYDROGENATED POLYISOBUTENE, HYDROXYACETOPHENONE, PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER, BUTYROSPERMUM PARKII (SHEA) BUTTER, BUTYROSPERMUM PARKII (SHEA) OIL, TRIETHYL CITRATE, PARFUM/FRAGRANCE, STEAROXY DIMETHICONE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PHOSPHOLIPIDS, POLYGLYCERYL-10 STEARATE, CARRAGEENAN, C12-14 PARETH-12, DISODIUM EDTA, METHYLPROPANEDIOL, O-CYMEN-5-OL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLIC /CAPRIC TRIGLYCERIDE, DIETHYLHEXYL SYRINGYLIDENEMALONATE, SODIUM HYDROXIDE, CHENOPODIUM QUINOA HUSK EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, SODIUM HYALURONATE, PHYSALIS PERUVIANA CALYX EXTRACT, PHENOXYETHANOL, CITRIC ACID, HYALURONIC ACID, SILANETRIOL, ETHYLHEXYLGLYCERIN, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT

Company Information

Made in Peru; Assembled in Columbia.

Distributed by YANBAL USA INC, 1341 W Newport Center Dr Deerfield Beach, Fl, 33442

Product Packaging

SENTIVA

EXTRACTO DIVINO

CREMA HIDRATANTE

REACTIVADORA DE

JUVENTUD

YOUTH RENEWAL

MOISTURIZING CREAM

SUNSCREEN

BROAD SPECTRUM SPF 20

YANBAL

40 ml 1.3 fl oz

INGREDIENTS AND APPEARANCE

YANBAL SENTIVA EXTRACTO DIVINO YOUTH RENEWAL MOISTURIZING SPF 20 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
EDETATE DISODIUM (UNII: 7FLD91C86K)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CARRAGEENAN (UNII: 5C69YCD2YJ)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
GLYCERIN (UNII: PDC6A3C0OX)
SHEANUT OIL (UNII: O88E196QRF)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYALURONIC ACID (UNII: S270N0TRQY)
ROSEMARY (UNII: IJ67X351P9)
C12-14 PARETH-12 (UNII: M0LJS773XW)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PROPANEDIOL (UNII: 5965N8W85T)
SILANETRIOL (UNII: E52D0J3TS5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0054-1	1 in 1 CARTON	10/01/2019
1		40 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2019

Labeler - Yanbal USA, Inc. (001801369)

Establishment
Name	Address	ID/FEI	Business Operations
Yanbal de Columbia S.A.S.		880215657	manufacture(23319-0054)

Establishment
Name	Address	ID/FEI	Business Operations
Unique S.A.		934396326	manufacture(23319-0054)