HYDRA LIFE WATER BB SPF 30 SHADE 020- benzophenone-3, octinoxate, phenylbenzimidazole sulfonic acid, titanium dioxide emulsion 
Parfums Christian Dior

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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Hydra Life Water BB SPF 30 - Shade 020

Drug Facts

Active ingredients

Benzophenone-3 3.00 %

Octinoxate 7.49 %

Phenylbenzimidazole sulfonic acid 2.00 %

Titanium Dioxide 3.20 %

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 swallowed, get medical help or contact a Poision 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, 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 a.m. - 2 p.m.

                  •  wear long-sleeve shirts, pants, hats, and sunglasses.

  • Children under 6 months of age: ask a doctor.

Other information

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

AQUA (WATER) • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE • GLYCERIN • BUTYLENE GLYCOL • PROPANEDIOL • CI 77891 (TITANIUM DIOXIDE) • PHENYL TRIMETHICONE • ALCOHOL • C12-15 ALKYL BENZOATE • SILICA • POLYGLYCERIN-3 • CI 77492 (IRON OXIDES) • BETAINE • PEG-12 DIMETHICONE • METHYL METHACRYLATE CROSSPOLYMER • PHENOXYETHANOL • GLYCERYL STEARATE • PEG-100 STEARATE • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER • CAPRYLYL GLYCOL • CI 77491 (IRON OXIDES) • SODIUM HYDROXIDE • SQUALANE • AMMONIUM ACRYLOYLDIMETHYL TAURATE/VP COPOLYMER • MENTHOXYPROPANEDIOL • PARFUM (FRAGRANCE) • CI 77499 (IRON OXIDES) • CENTELLA ASIATICA LEAF EXTRACT • SODIUM HYALURONATE • TETRASODIUM EDTA • TOCOPHERYL ACETATE • ALUMINA • XANTHAN GUM • POLYSORBATE 60 • POLYGLYCERYL-10 STEARATE • MALVA SYLVESTRIS (MALLOW) EXTRACT • SODIUM CITRATE • CITRIC ACID • SODBITAN ISOSTEARATE • BHT • HABERLEA RHODOPENSIS LEAF EXTRACT • SANGUISORBA OFFICINALIS ROOT EXTRACT • BENZYL ALCOHOL • LIMONENE • CITRONELLOL • CARAMEL • DEHYDROACETIC ACID • TOCOPHEROL.

Package Labeling:

LabelShade

HYDRA LIFE WATER BB SPF 30 SHADE 020 
benzophenone-3, octinoxate, phenylbenzimidazole sulfonic acid, titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61957-2218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74.9 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE32 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPANEDIOL (UNII: 5965N8W85T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
ALCOHOL (UNII: 3K9958V90M)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
BETAINE (UNII: 3SCV180C9W)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
HABERLEA RHODOPENSIS LEAF (UNII: N042Q65701)  
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
CARAMEL (UNII: T9D99G2B1R)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61957-2218-11 in 1 BOX01/17/201607/01/2018
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/17/201607/01/2018
Labeler - Parfums Christian Dior (275252245)
Establishment
NameAddressID/FEIBusiness Operations
Parfums Christian Dior396393746manufacture(61957-2218)

Revised: 5/2018
Document Id: 6d0853f5-4a0b-55ee-e053-2a91aa0aac06
Set id: b26e44e9-9489-484e-a93c-715b04731e62
Version: 4
Effective Time: 20180525
 
Parfums Christian Dior