THE ORDINARY SUNCARE INVISIBLE UV FILTERS WITH ANTIOXIDANTS SPF35- octinoxate, octisalate, avobenzone, octocrylene lotion

The Ordinary Suncare Invisible UV Filters with Antioxidants by

Drug Labeling and Warnings

The Ordinary Suncare Invisible UV Filters with Antioxidants by is a Otc medication manufactured, distributed, or labeled by Deciem Inc, Northwest Cosmetic Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Acrtive Ingredients

Octinoxate (7.44%)

Otisalate (4.98%)

Avobenzone (2.89%)

Octocrylene (0.79%)

Purpose

UV Filter

Uses

• helps prevent sunburn
• SPF 35

Warnings

​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.

​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

​For external use only.

Directions

•   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

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

Inactive Ingredients

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE ORDINARY SUNCARE INVISIBLE UV FILTERS WITH ANTIOXIDANTS  SPF35
octinoxate, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72208-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.44 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.98 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.89 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.79 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIMETHICONE (UNII: 92RU3N3Y1O)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
ASTAXANTHIN (UNII: 8XPW32PR7I)
TASMANNIA LANCEOLATA WHOLE (UNII: RQ58K8571Z)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
PICEA MARIANA WHOLE (UNII: U37W7O088B)
ARGININE (UNII: 94ZLA3W45F)
ASPARTIC ACID (UNII: 30KYC7MIAI)
GLYCINE (UNII: TE7660XO1C)
ALANINE (UNII: OF5P57N2ZX)
SERINE (UNII: 452VLY9402)
VALINE (UNII: HG18B9YRS7)
ISOLEUCINE (UNII: 04Y7590D77)
PROLINE (UNII: 9DLQ4CIU6V)
THREONINE (UNII: 2ZD004190S)
HISTIDINE (UNII: 4QD397987E)
PHENYLALANINE (UNII: 47E5O17Y3R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PIDOLIC ACID (UNII: SZB83O1W42)
SODIUM LACTATE (UNII: TU7HW0W0QT)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MALTOSE (UNII: XJ6S9RV06F)
FRUCTOSE (UNII: 6YSS42VSEV)
TREHALOSE (UNII: B8WCK70T7I)
UREA (UNII: 8W8T17847W)
ALLANTOIN (UNII: 344S277G0Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72208-354-02	1 in 1 CARTON	06/12/2018
1	NDC: 72208-354-01	50 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 final	part352	06/12/2018

Labeler - Deciem Inc (203133665)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Labs		929572014	manufacture(72208-354) , pack(72208-354)