nydg discovery set

nydg discovery set
SPL v1
SPL
SPL Set ID 186c094e-e14b-474e-b7b0-a42908660995
Route
topical
Published
Effective Date 2018-03-01
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
Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings

For external use only

Uses
  • Helps prevent sunburn
  • Retains SPF after 80 minutes of activity in the water or perspiring
Purpose

Sunscreen

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
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

Description

Drug Facts

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

Active Ingredient

Zinc Oxide 17.5%

Principal Display Panel Kit Carton

N

Y

NEW YORK

DERMATOLOGY

GROUP

D

G

Structured Label Content

Warnings

For external use only

Uses
  • Helps prevent sunburn
  • Retains SPF after 80 minutes of activity in the water or perspiring
Purpose

Sunscreen

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
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

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

Active Ingredient

Zinc Oxide 17.5%

Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

N

Y

NEW YORK

DERMATOLOGY

GROUP

D

G

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:33.662002 · Updated: 2026-03-14T22:55:06.338046