Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35: Package Insert and Label Information

KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35- zinc oxide lotion
Kinfield, Inc.

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.

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

81750-040-04
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE
ISOAMYL LAURATE
POLYGLYCERYL-2 OLEATE
HYDROGENATED METHYL ABIETATE
POLYHYDROXYSTEARIC ACID (2300 MW)
GLYCINE
SODIUM CHLORIDE
POLYGLYCERYL-2 STEARATE
TRIETHOXYCAPRYLYLSILANE
GLYCERYL CAPRATE
CAPRYLHYDROXAMIC ACID
ALOE VERA LEAF
COCO-CAPRYLATE
MACROCYSTIS PYRIFERA
ALLANTOIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81750-040-04 1 TUBE in 1 PACKAGE contains a TUBE
1 114 g in 1 TUBE This package is contained within the PACKAGE (81750-040-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/14/2022
Labeler — Kinfield, Inc. (049511853)

Revised: 06/2022 Kinfield, Inc.

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