OTC Medication Information: TRADER JOES ZINC OXIDE SUNSCREEN SPF 40

TRADER JOES ZINC OXIDE SUNSCREEN SPF 40- zinc oxide lotion
Trader Joe’s Company

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 ingredient

Zinc Oxide 20.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures ( See Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

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 swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Apply liberally to face and body 15 minutes before sun exposure.
• Reapply after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours.
• Children under 6 months: ask a doctor.

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 15 value or higher along with other sun protection measures including:

• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long sleeved shirts, pants, hats and sunglasses.

Other information

• Protect the product in this container from excessive heat and direct sun
• store at room temperature 59-86°F (15-30°C)
• May stain some fabrics.

Inactive ingredients

WATER (AQUA), ISOPROPYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED METHYL ABIETATE, GLYCERIN, SORBITAN LAURATE, OCTYLDODECYL CITRATE CROSSPOLYMER, POLYHYDROXYSTEARIC ACID, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, PHENOXYETHANOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, SODIUM STEAROYL GLUTAMATE, METHYLCELLULOSE, SODIUM LAURYL GLUCOSE, CARBOXYLATE, POLYGLYCERYL-4 LAURATE, LAURYL GLUCOSIDE, XANTHAN GUM, DILAURYL CITRATE, ETHYLHEXYLGLYCERIN, SODIUM PHYTATE, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, ALOE BARBADENSIS LEAF JUICE, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, LONICERA CAPRIFOLIUM (HONEYSUCKLE) FLOWER EXTRACT, POPULUS TREMULOIDES BARK EXTRACT, TOCOPHEROL, GLYCINE SOJA (SOYBEAN) OIL, GLUCONOLACTONE, GINKGO BILOBA LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, BAMBUSA ARUNDINACEA STEM EXTRACT.

Questions or comments?

1- 626-599-3700 Monday – Friday 9 AM – 5 PM PST

Packaging

TRADER JOES ZINC OXIDE SUNSCREEN SPF 40 zinc oxide lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71270-151 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC CATION) ZINC CATION 20.5 g in 100 g

Inactive Ingredients Ingredient Name Strength WATER ISOPROPYL PALMITATE MEDIUM-CHAIN TRIGLYCERIDES HYDROGENATED METHYL ABIETATE GLYCERIN SORBITAN MONOLAURATE OCTYLDODECYL LACTATE POLYHYDROXYSTEARIC ACID (2300 MW) JOJOBA OIL PHENOXYETHANOL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER SODIUM STEAROYL GLUTAMATE METHYLCELLULOSE (100 CPS) SODIUM LAURYL GLYCOL CARBOXYLATE POLYGLYCERYL-4 OLEATE LAURYL GLUCOSIDE XANTHAN GUM DILAURYL CITRATE ETHYLHEXYLGLYCERIN PHYTATE SODIUM LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE ALOE VERA LEAF LONICERA JAPONICA FLOWER LONICERA CAPRIFOLIUM FLOWER POPULUS TREMULOIDES BARK TOCOPHEROL SOYBEAN OIL GLUCONOLACTONE GINKGO BILOBA WHOLE CAMELLIA SINENSIS WHOLE BAMBUSA ARUNDINACEA STEM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71270-151-11 142 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/27/2019

Labeler — Trader Joe’s Company (006226666)

Revised: 01/2023 Trader Joe’s Company