OTC Medication Information: NATURAL SUN ECO SUPER PERFECT SPF 50

NATURAL SUN ECO SUPER PERFECT SPF 50- octinoxate, titanium dioxide, octisalate and avobenzone cream
THEFACESHOP CO., LTD.

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.

Active Ingredients

Avobenzone 3.0 %
Octinoxate 7.2 %
Octisalate 4.7%
Titanium Dioxide 3.7%

Purpose

Sunscreen
Sunscreen
Sunscreen
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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor.
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.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.

Apply an adequate amount on the face and neck at the final stage of skincare.

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

May stain or damage some fabrics or surfaces.

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, DICAPRYLYL CARBONATE, OCTYLDODECYL NEOPENTANOATE, SILICA, METHICONE, POLYGLYCERYL-6 POLYRICINOLEATE, PROPANEDIOL, CYCLOHEXASILOXANE, ALCOHOL DENAT., OCTOCRYLENE, POLYGLYCERYL-6 STEARATE, POLYGLYCERYL-6 BEHENATE, CAPRYLIC/CAPRIC GLYCERIDES, CAPRYLHYDROXAMIC ACID, PEG-100 STEARATE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, POLYETHYLENE, PANTHENOL, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, ILLICIUM VERUM (ANISE) FRUIT EXTRACT, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, XANTHAN GUM, POLYESTER-5, POTASSIUM HYDROXIDE, TRISODIUM EDTA, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, SODIUM BENZOATE, MENTHYL PCA, SODIUM PCA, FRAGRANCE

Questions or comments? Call 1-866-638-8417

Distributed by:

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

NATURAL SUN ECO

SUPER PERFECT SUNSCREEN CREAM

SPF 50+ PA+++

Contains sunflower sprout extract 5000 µg

A daily sun cream that screens both UVA and UVB rays.

Protects skin better and has less oiliness, making it usable every day.

Helps prevent sunburn.

Filters/screens UVA/UVB harmful rays.

Label
(click image for full-size original)
NATURAL SUN ECO SUPER PERFECT SPF 50
avobenzone, octinoxate, octisalate, titanium dioxide cream cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-173
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.6 g in 50 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.85 g in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE 2.35 g in 50 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 1.5 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51523-173-02 1 TUBE in 1 CARTON contains a TUBE
1 50 mL in 1 TUBE This package is contained within the CARTON (51523-173-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/01/2015
Labeler — THEFACESHOP CO., LTD. (688329416)
Registrant — THEFACESHOP NORTH AMERICA, INC. (620459193)
Establishment
Name Address ID/FEI Operations
THEFACESHOP CO., LTD. 688329416 label (51523-173)

Revised: 09/2015 THEFACESHOP CO., LTD.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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