ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40- zinc oxide lotion

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

Buy It Now

Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Taylor James Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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 Stop use and ask a doctor if rash occurs or irritation develops and lasts.
Authorization status:
OTC monograph final
Authorization number:
75936-223-01

ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40- zinc oxide lotion

Taylor James 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.

----------

Zinc Screen Broad Spectrum Sunscreen SPF 40

Active Ingredients Purpose

Zinc Oxide 13% 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

Keep out of reach of children.

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

Stop use and ask a doctor if rash occurs or irritation develops and lasts.

Warnings

Do not use on damaged or broken skin

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

For external use only

Directions

Apply generously and evenly 15 minutes before sun exposure

Use a water-resistant sunscreen if swimming or sweating

Reapply 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 your time in the sun, especially from 10

a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: ask a doctor.

Inactive Ingredients

Water, Tetradecane, Cetearyl Nonanoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride,

Isopropyl Myristate, Glycerin, Polyglyceryl-3 Diisostearate, Mica, Propanediol, Disteardimonium

Hectorite, Gluconolactone, Polyglyceryl-6 Polyricinoleate, Brassica Campestris/Aleurites Fordi Oil

Copolymer, Polyhydrostearic Acid, Sodium Chloride, Magnesium Sulfate, Fructose, Octyldodecyl

Oleate, Tocopherol, Cocos Nucifera (Coconut) Fruit Extract, Sodium Benzoate, Iron oxides (CI

77492), Dodecane, Hexadecane, Titanium Dioxide (CI 77891), Withania Somnifera Flower Extract, Iron

Oxides (CI 77491), Vaccinium Angustifolia (Blueberry) Fruit Extract, Silica, Calcium Gluconate

Zinc Screen

100% Mineral Lotion

Broad Spectrum SPF 40 PA+++

1.7 fl. oz. / 50 ml.

ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:759 36 -223

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

13 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLUCO NO LACTO NE (UNII: WQ29 KQ9 POT)

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

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

O CTYLDO DECYL O LEATE (UNII: MCA43PK7MH)

CALCIUM GLUCO NATE (UNII: SQE6 VB453K)

TETRADECANE (UNII: 0 3LY78 4Y58 )

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

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

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

WATER (UNII: 0 59 QF0 KO0 R)

MAGNESIUM SULFATE ANHYDRO US (UNII: ML30 MJ2U7I)

WITHANIA SO MNIFERA FLO WER (UNII: 2HZ9 5R70 8 2)

HEXADECANE (UNII: F8 Z0 0 SHP6 Q)

CETEARYL NO NANO ATE (UNII: F6 ZWV2F36 1)

MICA (UNII: V8 A1AW0 8 8 0 )

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

GLYCERIN (UNII: PDC6 A3C0 OX)

CO CO NUT (UNII: 3RT3536 DHY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

DO DECANE (UNII: 11A38 6 X1QH)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

LO WBUSH BLUEBERRY (UNII: G9 0 PX41VP0 )

PO LYGLYCERYL-3 DIISO STEARATE (UNII: 46 P231IQV8 )

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

FRUCTO SE (UNII: 6 YSS42VSEV)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:759 36 -223-0 1

50 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/30 /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 final

pa rt352

0 4/30 /20 19

Taylor James Ltd.

Labeler -

T aylor James Ltd. (033381850)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

No rthwest Co smetic Labs

9 29 5720 14

ma nufa c ture (759 36 -223)

Revised: 4/2019

Similar products

Search alerts related to this product

View documents history

Share this information