SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM

SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM by

Drug Labeling and Warnings

SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM by is a Otc medication manufactured, distributed, or labeled by Guerlain. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM- octinoxate, titanium dioxide cream 
Guerlain

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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SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM

GUERLAIN SUPER AQUA-SERUM BB HYDRA + BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM

Active ingredients

Octinoxate 7.49%
Titanium Dioxide 3.84%

Purpose

sunscreen

Uses

• Helps prevent sunburn
  

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• Apply liberally 15 minutes before sun exposure.
• reapply at least every two 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, regularly 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-sleeved shirts, pants, hats and sunglasses
• Children under 6 months of age: Ask a doctor

Inactive ingredients

AQUA (WATER) - GLYCERIN - BUTYLENE GLYCOL - SQUALANE - PROPANEDIOL - PHENYL TRIMETHICONE - ETHYLHEXYL ISONONANOATE - SILICA - GLYCERYL STEARATE SE - PEG-60 HYDROGENATED CASTOR OIL - PENTYLENE GLYCOL - PHENOXYETHANOL - AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER - STEARYL ALCOHOL - DICAPRYLYL ETHER - STEARIC ACID - PARFUM (FRAGRANCE) - HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER - PHOSPHOLIPIDS - SODIUM HYALURONATE - TOCOPHERYL ACETATE - HYDROLYZED MILLET - ALUMINA - XYLOSE - SODIUM CITRATE - POLYGLYCERYL-10 STEARATE - DISODIUM EDTA - RUSCUS ACULEATUS ROOT EXTRACT - POLYSORBATE 50 - VIOLA TRICOLOR EXTRACT - CITRONELLOL - CITRIC ACID - BHT - GERANIOL - BUTYLPHENYL METHYLPROPIONAL - HEXYL CINNAMAL - BENZYL SALICYLATE - LINALOOL - ETHYLHEXYLGLYCERIN - TOCOPHEROL - [MAY CONTAIN: CI 77891 (TITANIUM DIOXIDE) - CI 77492, CI 77491, CI 77499 (IRON OXIDES)] (08038)

Other information

• Protects this product from excessive heat and direct sun.
  

Question or comments?

In USA: 19 East, 57 th Street, New York, NY 10022

GUERLAIN SUPER AQUA-SERUM BB HYDRA + BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM

SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-0079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	38.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SQUALANE (UNII: GW89575KF9)
PROPANEDIOL (UNII: 5965N8W85T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM OXIDE (UNII: LMI26O6933)
XYLOSE (UNII: A1TA934AKO)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
EDETATE DISODIUM (UNII: 7FLD91C86K)
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)
VIOLA TRICOLOR (UNII: 9Q24RAI43V)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GERANIOL (UNII: L837108USY)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49817-0079-1	1 in 1 CARTON	04/10/2014	12/31/2015
1		40 mL in 1 TUBE; 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	04/10/2014	12/31/2015

Labeler - Guerlain (266623064)

Establishment
Name	Address	ID/FEI	Business Operations
Guerlain		266623064	manufacture(49817-0079)

Revised: 12/2019

Document Id: 9948546f-e54d-7f2c-e053-2995a90a7021

34390-5

Set id: 5d68c803-8624-41ff-9294-706d764ee7a4

Version: 6

Effective Time: 20191209

 

Guerlain