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

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SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49817-0079
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74.9 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE38.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49817-0079-11 in 1 CARTON04/10/201412/31/2015
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/10/201412/31/2015
Labeler - Guerlain (266623064)
Establishment
NameAddressID/FEIBusiness Operations
Guerlain266623064manufacture(49817-0079)

Revised: 12/2019
 
Guerlain