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NDC 81750-0040-04 Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35 20 g/100g Details

Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35 20 g/100g

Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Kinfield, Inc.. The primary component is ZINC OXIDE.

Product Information

NDC	81750-0040
Product ID	81750-040_e16d1ca7-4d3c-8073-e053-2a95a90a920b
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	Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35
Proprietary Name Suffix	n/a
Non-Proprietary Name	Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	Kinfield, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 81750-0040-04 (81750004004)

Pricing Information	N/A
NDC Package Code	81750-040-04
Billing NDC	81750004004
Package	1 TUBE in 1 PACKAGE (81750-040-04) / 114 g in 1 TUBE
Marketing Start Date	2022-06-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 77670ef8-45e3-4ffc-880b-dda43af0fcce Details

Active Ingredients

Zinc Oxide 20%

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 docor if rash occurs

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

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• 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 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-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Inactive ingredients

Water, Capric/Caprylic Triglyceride, Isoamyl Laurate, Polyglyceryl-2 Oleate, Hydrogenated Methyl Abietate, Polyhydrostearic Acide, Glycerin, Sodium Chloride, Polyglyceryl-2 Stearate, Triethoxycaprylylsilane, Glyceryl Caprylate, Caprylhydroxamic Acid, Aloe Barbadnesis Leaf Extract, Coco-Caprylate, Macrocystis Pyrifera (Sea Kelp) Extract, Allantoin, Natural Fragrance

Other Information

• protect the product in this container from excessive

heat and direct sun

Questions or Comments?

Conctact us at www.kinfield.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35

kinfield cloud cover mineral body sunscreen broad spectrum spf 35 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81750-040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCINE (UNII: TE7660XO1C)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERYL CAPRATE (UNII: 197M6VFC1W)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO-CAPRYLATE (UNII: 4828G836N6)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
ALLANTOIN (UNII: 344S277G0Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81750-040-04	1 in 1 PACKAGE	06/14/2022
1		114 g 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 final	part352	06/14/2022

Labeler - Kinfield, Inc. (049511853)

Revised: 6/2022

Document Id: e16d1ca7-4d3c-8073-e053-2a95a90a920b

Set id: 77670ef8-45e3-4ffc-880b-dda43af0fcce

Version: 1

Effective Time: 20220614