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NDC 72894-0003-01 NUORI MINERAL DEFENCE SUNSCREEN SPF 30 230 mg/mL Details

NUORI MINERAL DEFENCE SUNSCREEN SPF 30 230 mg/mL

NUORI MINERAL DEFENCE SUNSCREEN 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	72894-0003
Product ID	72894-003_ed24547f-87a6-3b47-e053-2a95a90a40f3
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 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	230
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	2024-12-31

Package

Package Images

NDC 72894-0003-01 (72894000301)

Pricing Information	N/A
NDC Package Code	72894-003-01
Billing NDC	72894000301
Package	1 TUBE in 1 CARTON (72894-003-01) / 50 mL in 1 TUBE
Marketing Start Date	2019-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8695330d-2426-f590-e053-2a91aa0a86ba Details

Drug Facts

Active Ingredients

Zinc Oxide 23%

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 of age: ask a doctor.

Inactive ingredients

Aqua (water), caprylic/capric triglyceride, caprylyl caprylate/caprate, glycerin, silica, arachidyl alcohol, cetearyl alcohol, pongamia glabra (karanja) seed oil, helianthus annuus (sunflower) seed oil, daucus carota sativa (carrot) seed oil, daucus carota sativa (carrot) root extract, pinus pinaster (french maritime pine) bark extract, cetearyl olivate, sorbitan olivate, glyceryl oleate, microcrystalline cellulose, behenyl alcohol, arachidyl glucoside, coco-glucoside, lecithin, polyglyceryl-3 polyricinoleate, hydrogenated palm glycerides citrate, polyhydroxystearic acid, isostearic acid, tocopheryl acetate (vitamin e), ascorbyl palmitate, tocopherol (vitamin e), beta-carotene, glucose, xanthan gum, cellulose gum, citric acid, sodium chloride, hydroxyacetophenone, benzyl alcohol.

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

HIGH PROTECTION

BROAD SPECTRUM SPF 30

UVA & UVB

ALL-NATURAL

PROVEN RESULTS

50ml 1.7floz

INGREDIENTS AND APPEARANCE

NUORI MINERAL DEFENCE SUNSCREEN SPF 30

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72894-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	230 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOSTEARIC ACID (UNII: X33R8U0062)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
KARUM SEED OIL (UNII: 62160PU6FJ)
SORBITAN OLIVATE (UNII: MDL271E3GR)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CARROT SEED OIL (UNII: 595AO13F11)
GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TOCOPHEROL (UNII: R0ZB2556P8)
MARITIME PINE (UNII: 50JZ5Z98QY)
BETA CAROTENE (UNII: 01YAE03M7J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
CARROT (UNII: L56Z1JK48B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
COCO GLUCOSIDE (UNII: ICS790225B)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72894-003-01	1 in 1 CARTON	06/01/2019
1		50 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	06/01/2019

Labeler - NUORI ApS (305146468)

Revised: 11/2022

Document Id: ed24547f-87a6-3b47-e053-2a95a90a40f3

Set id: 8695330d-2426-f590-e053-2a91aa0a86ba

Version: 3

Effective Time: 20221110