TRADER JOES ZINC OXIDE SUNSCREEN SPF 40- zinc oxide lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
Trader Joe's Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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.
Authorization status:
OTC monograph not final
Authorization number:
71270-151-11

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.

----------

TRADER JOE’S ZINC OXIDE SUNSCREEN LOTION SPF 40

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71270 -151

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

20 .5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

HYDRO GENATED METHYL ABIETATE (UNII: A23O70 9 X8 O)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO RBITAN MO NO LAURATE (UNII: 6 W9 PS8 B71J)

O CTYLDO DECYL LACTATE (UNII: 8 JKW8 M5W35)

PO LYHYDRO XYSTEARIC ACID ( 2 3 0 0 MW) (UNII: YXH47AOU0 F)

JO JO BA O IL (UNII: 724GKU717M)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

AMMO NIUM ACRYLO YLDIMETHYLTAURATE/VP CO PO LYMER (UNII: W59 H9 29 6 ZG)

SO DIUM STEARO YL GLUTAMATE (UNII: 6 5A9 F4P0 24)

METHYLCELLULO SE ( 10 0 CPS) (UNII: 4GFU244C4J)

SO DIUM LAURYL GLYCO L CARBO XYLATE (UNII: 8 L0 472VMYL)

PO LYGLYCERYL-4 O LEATE (UNII: 15B0 5TY4GX)

LAURYL GLUCO SIDE (UNII: 76 LN7P7UCU)

XANTHAN GUM (UNII: TTV12P4NEE)

DILAURYL CITRATE (UNII: 5OYS3G30 6 B)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

PHYTATE SO DIUM (UNII: 8 8 49 6 G1ERL)

LEUCO NO STO C/RADISH RO O T FERMENT FILTRATE (UNII: D2QHA0 3458 )

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

LO NICERA JAPO NICA FLO WER (UNII: 446 5L2WS4Y)

LO NICERA CAPRIFO LIUM FLO WER (UNII: 5N1WD9 78 4U)

PO PULUS TREMULO IDES BARK (UNII: 5543O0 CEID)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

SO YBEAN O IL (UNII: 241ATL177A)

GLUCO NO LACTO NE (UNII: WQ29 KQ9 POT)

GINKGO BILO BA WHO LE (UNII: 6 6 0 48 6 U6 OI)

CAMELLIA SINENSIS WHO LE (UNII: C5M458 5ZBZ)

BAMBUSA ARUNDINACEA STEM (UNII: NRA449 7HC5)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71270 -151-11

142 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 2/27/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 2/27/20 19

Labeler -

T rader Joe's Company (006226666)

Trader Joe's Company

Registrant -

T rader Joe's Company (006226666)

Revised: 3/2019

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