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NDC 72894-0063-01 NUORI MINERAL DEFENCE SUNSCREEN FACE AND BODY SPF 30 200 mg/mL Details

NUORI MINERAL DEFENCE SUNSCREEN FACE AND BODY SPF 30 200 mg/mL

NUORI MINERAL DEFENCE SUNSCREEN FACE AND BODY SPF 30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by NUORI ApS. The primary component is ZINC OXIDE.

Product Information

NDC	72894-0063
Product ID	72894-063_ed244736-9056-77b4-e053-2995a90a4d25
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	NUORI MINERAL DEFENCE SUNSCREEN FACE AND BODY SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/mL
Substance Name	ZINC OXIDE
Labeler Name	NUORI ApS
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	n/a

Package

Package Images

NDC 72894-0063-01 (72894006301)

Pricing Information	N/A
NDC Package Code	72894-063-01
Billing NDC	72894006301
Package	1 TUBE in 1 CARTON (72894-063-01) / 150 mL in 1 TUBE
Marketing Start Date	2020-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9dd8339b-7870-0e23-e053-2995a90ac5f6 Details

Drug Facts

Active Ingredients

Zinc Oxide 20%

Purpose: Sunscreen

Uses

Helps prevent sunburn
Higher SPF gives more sunburn protection
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.

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

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

Stop use and ask a doctor if rash occurs.

Directions

Apply liberally on clean, moisturized skin 15 minutes before sun exposure.
Reapply at least every 2 hours.
For daily use, allow product to absorb completely before applying makeup.
Use a water resistant sunscreen if swimming or sweating.
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 10 a.m.-2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses.

Children under 6 months: Ask a doctor.

Inactive ingredients

Aqua (water), coco-caprylate/caprate, caprylic/capric triglyceride, ethyl macadamiate, butyrospermum parkii (shea) butter, propanediol, polyglyceryl-6 polyhydroxystearate, cetyl alcohol, pongamia glabra (karanja) seed oil, polyglyceryl-6 polyricinoleate, sorbitol, arachidyl alcohol, benzyl alcohol, hydroxyacetophenone, helianthus annuus (sunflower) seed oil, behenyl alcohol, hydrolyzed jojoba esters, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, polyhydroxystearic acid, arachidyl glucoside, sclerotium gum, passiflora edulis (passionfruit) fruit extract, tocopherol (vitamin E), beta-carotene, daucus carota sativa (carrot) root extract, daucus carota sativa (carrot) seed oil, glucose, malic acid, ascorbyl palmitate, citric acid.

Other information

Protect the product in this container from excessive heat and direct sun
You may report a serious adverse reaction to: NUORI Inc., 228 Park Ave S, Ste 300, New York, NY 10003

Questions?

send them to [email protected]

Product Packaging

NUORI

SUN

MINERAL DEFENCE SUNSCREEN

FACE & BODY

HIGH PROTECTION

BROAD SPECTRUM SPF 30

UVA & UVB

FRESH SKINCARE

150ml 5.1fl oz

INGREDIENTS AND APPEARANCE

NUORI MINERAL DEFENCE SUNSCREEN FACE AND BODY SPF 30

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72894-063
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PASSIFLORA EDULIS FRUIT (UNII: 602YE42W5R)
DOCOSANOL (UNII: 9G1OE216XY)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
SORBITOL (UNII: 506T60A25R)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
KARUM SEED OIL (UNII: 62160PU6FJ)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
BETA CAROTENE (UNII: 01YAE03M7J)
ISOSTEARIC ACID (UNII: X33R8U0062)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CARROT SEED OIL (UNII: 595AO13F11)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
CARROT (UNII: L56Z1JK48B)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TOCOPHEROL (UNII: R0ZB2556P8)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
MALIC ACID (UNII: 817L1N4CKP)
SHEA BUTTER (UNII: K49155WL9Y)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL ALCOHOL (UNII: 936JST6JCN)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72894-063-01	1 in 1 CARTON	04/01/2020
1		150 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2020	06/06/2023

Labeler - NUORI ApS (305146468)

Revised: 11/2022

Document Id: ed244736-9056-77b4-e053-2995a90a4d25

Set id: 9dd8339b-7870-0e23-e053-2995a90ac5f6

Version: 2

Effective Time: 20221110