Label: DR.JART EVERY SUN DAY SUN FLUID- homosalate, octinoxate, octisalate, octocrylene, avobenzone liquid
- NDC Code(s): 49404-307-01
- Packager: Have & Be Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
-
Directions
■ 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 am
to 2 pm
* wear long-sleeved shirts, pants, hats, and
sunglasses
■ Children under 6 months of age: ask a doctor -
Inactive ingredients
WATER\AQUA\EAU,
PROPANEDIOL, ALCOHOL
DENAT., BENZOTRIAZOLYL
DODECYL P-CRESOL,
PENTYLENE GLYCOL,
1,2-HEXANEDIOL, SILICA,
DIMETHICONE/VINYL
DIMETHICONE CROSSPOLYMER,
AMMONIUM
ACRYLOYLDIMETHYLTAURATE/
VP COPOLYMER,
STYRENE/ACRYLATES
COPOLYMER, LAVANDULA
ANGUSTIFOLIA (LAVENDER) OIL,
ETHYLHEXYLGLYCERIN,
HYDROXYPROPYL
METHYLCELLULOSE STEAROXY
ETHER, POLYACRYLATE
CROSSPOLYMER-6, BUTYLENE
GLYCOL, LINALOOL, LIMONENE,
BHT, T-BUTYL ALCOHOL,
TOCOPHEROL <ILN50939> - Other information
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR.JART EVERY SUN DAY SUN FLUID
homosalate, octinoxate, octisalate, octocrylene, avobenzone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49404-307 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 40 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 68 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPANEDIOL (UNII: 5965N8W85T) LAVENDER OIL (UNII: ZBP1YXW0H8) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) PENTYLENE GLYCOL (UNII: 50C1307PZG) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) TOCOPHEROL (UNII: R0ZB2556P8) ALCOHOL (UNII: 3K9958V90M) HYPROMELLOSE 2208 0.45% STEAROXY ETHER (UNII: MG58AH4FJ8) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49404-307-01 1 in 1 CARTON 08/11/2023 1 100 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 08/11/2023 Labeler - Have & Be Co., Ltd. (690400408) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations HK Kolmar Canada, Inc 243501959 manufacture(49404-307)
