FDA.reportPublic FDA data

The Ordinary Suncare Invisible UV Filters with Antioxidants

Manufacturer
Deciem Inc | Northwest Cosmetic Labs
Effective date
2020-06-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:24:57

Label at a glance#

ProductThe Ordinary Suncare Invisible UV Filters with Antioxidants SPF35
Active ingredientOCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure7 sections

Indications and uses

helps prevent sunburn SPF 35

Dosage and administration

  apply liberally and evenly to face 15 minutes before sun exposue   for children under 6 months of age: Ask a doctor prior to use. ​Reapply ​ Reapply at lease every 2 hours use a water resistant sunscreen if swimming or sweating 

Label contents#

Full prescribing information#

Acrtive Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate (7.44%)

Otisalate (4.98%)

Avobenzone (2.89%)

Octocrylene (0.79%)

Purpose

OTC - PURPOSE SECTION

UV Filter

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • SPF 35

Warnings

WARNINGS SECTION

​Skin Cancer/Skin Aging Alert; ​Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, ​not​ skin cancer or early skin aging.

OTC - DO NOT USE SECTION

​Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

​When using this product keep out of eyes.  Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

​For external use only.

Directions

DOSAGE & ADMINISTRATION SECTION

  •   apply liberally and evenly to face 15 minutes before sun exposue
  •   for children under 6 months of age: Ask a doctor prior to use.
  • ​Reapply
  • ​Reapply at lease every 2 hours
  • use a water resistant sunscreen if swimming or sweating 

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Isodecyl Neopentanoate, Dimethicone, Cellulose acetate, Glycerin, PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Styrene/Acrylates Copolymer,  Astaxanthin, Tasmannia Lanceolata Fruit/Leaf Extract, Haematococcus Pluvialis Extract, Picea Mariana Bark Extract, Arginine, Aspartic Acid, Glycine, Alanine, Serine, Valine, Isoleucine, Proline, Threonine, Histidine, Phenylalanine, Sodium PCA, PCA, Sodium Lactate, Glucose, Maltose, Fructose, Trehalose, Urea, Allantoin, Sodium Hyaluronate, Isochrysis Galbana Extract, Lysolecithin, Polyglyceryl-10 Oleate, Polyglyceryl-10 Stearate, Caprylic/Capric Triglyceride, Pentylene Glycol, Dipropylene Glycol, Xanthan gum, Trisodium Ethylenediamine Disuccinate, Tocopherol, Citric Acid, Sodium Chloride, Sodium Hydroxide, Phenoxyethanol, Chlorphenesin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OrdinarySPF35OrdinarySPF35

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 52 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72208-35472208-354-01, 72208-354-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 50 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
DIMETHICONE92RU3N3Y1OIACT
CELLULOSE ACETATE3J2P07GVB6IACT
GLYCERINPDC6A3C0OXIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
POLYETHYLENE GLYCOL 500761NX2Q08YIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
ASTAXANTHIN8XPW32PR7IIACT
TASMANNIA LANCEOLATA WHOLERQ58K8571ZIACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
PICEA MARIANA WHOLEU37W7O088BIACT
ARGININE94ZLA3W45FIACT
ASPARTIC ACID30KYC7MIAIIACT
GLYCINETE7660XO1CIACT
ALANINEOF5P57N2ZXIACT
SERINE452VLY9402IACT
VALINEHG18B9YRS7IACT
ISOLEUCINE04Y7590D77IACT
PROLINE9DLQ4CIU6VIACT
THREONINE2ZD004190SIACT
HISTIDINE4QD397987EIACT
PHENYLALANINE47E5O17Y3RIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PIDOLIC ACIDSZB83O1W42IACT
SODIUM LACTATETU7HW0W0QTIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MALTOSEXJ6S9RV06FIACT
FRUCTOSE6YSS42VSEVIACT
TREHALOSEB8WCK70T7IIACT
UREA8W8T17847WIACT
ALLANTOIN344S277G0ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
DIPROPYLENE GLYCOLE107L85C40IACT
POLYGLYCERYL-10 OLEATE55C81W76DHIACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9127e440-8124-430b-8454-fd271ff972a63a566d96-ac98-4fc0-8f05-24bd051e3ac22020-12-08WarningsExact identifier
spl set id: 3a566d96-ac98-4fc0-8f05-24bd051e3ac2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.