Chem-free Active Defense Spf 30

Chem-free Active Defense Spf 30
SPL v1
SPL
SPL Set ID 35c10a68-317c-4a17-b182-78eb5a90c3d2
Route
TOPICAL
Published
Effective Date 2018-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (175 mg)
Inactive Ingredients
Water Isononyl Isononanoate Butyloctyl Salicylate Medium-chain Triglycerides Dimethicone Hexylene Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Argan Oil Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Polyglyceryl-4 Isostearate .alpha.-tocopherol Acetate Polyglyceryl-3 Ricinoleate Polyhydroxystearic Acid (2300 Mw) Squalane Phenoxyethanol Isostearic Acid Lecithin, Soybean Sodium Chloride Hexyl Laurate Ethylhexylglycerin Levomenol Caprylyl Glycol Polysorbate 60 Chlorphenesin Edetate Disodium Farnesol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-05-01

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn
  • Retains SPF after 80 minutes of activity in the water or perspiring
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

Directions

Apply generously 15 minutes before sun exposure.

Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

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 10am–2pm
    • wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: Ask a doctor
Active Ingredient

Zinc Oxide 17.5%

Other Information

Protect this product from excessive heat and direct sun. Report a serious adverse event reaction to: van laere llc. 119 Fifth Avenue, New York, NY 10003

Inactive Ingredients

Water (Aqua), Isononyl Isononanoate, Caprylic/Capric Triglyceride, Dimethicone, Hexylene Glycol, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Argania Spinosa Kernel Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copoly Polyglyceryl-4 Isostearate, Tocopheryl Acetate, Polyhydroxystearic Acid, Squalane, Polyglyceryl-3 -Poyricinoleate, Phenoxyethanol, Lecithin, Sodium Chloride, Isostearic Acid, Hexyl Laurate Ethylhexylglycerin, Bisabolol, Caprylyl Glycol, Polysorbate 60, Chlorphenesin, Disodium EDTA

Principal Display Panel 30 Ml Tube Carton

N

Y

NEW YORK

DERMATOLOGY

GROUP

D

G

Chem-Free Active Defense SPF30


Structured Label Content

Uses
  • Helps prevent sunburn
  • Retains SPF after 80 minutes of activity in the water or perspiring
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

Directions

Apply generously 15 minutes before sun exposure.

Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

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 10am–2pm
    • wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: Ask a doctor
Active Ingredient

Zinc Oxide 17.5%

Other Information (Other information)

Protect this product from excessive heat and direct sun. Report a serious adverse event reaction to: van laere llc. 119 Fifth Avenue, New York, NY 10003

Inactive Ingredients

Water (Aqua), Isononyl Isononanoate, Caprylic/Capric Triglyceride, Dimethicone, Hexylene Glycol, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Argania Spinosa Kernel Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copoly Polyglyceryl-4 Isostearate, Tocopheryl Acetate, Polyhydroxystearic Acid, Squalane, Polyglyceryl-3 -Poyricinoleate, Phenoxyethanol, Lecithin, Sodium Chloride, Isostearic Acid, Hexyl Laurate Ethylhexylglycerin, Bisabolol, Caprylyl Glycol, Polysorbate 60, Chlorphenesin, Disodium EDTA

Principal Display Panel 30 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton)

N

Y

NEW YORK

DERMATOLOGY

GROUP

D

G

Chem-Free Active Defense SPF30


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)