OTC Medication Information: Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And Primer

KYPRIS POT OF SHADE HELIOTROPIC BROAD SPECTRUM SPF 30 SUNSCREEN AND PRIMER- zinc oxide cream
Kypris Beauty LLC

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.

​Drug Facts

​Active ingredient

Zinc Oxide 20%

​Purpose

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.

​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 doctor if

  • rash occurs

Keep out of reach of children.

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

​Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • 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 10am to 2pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses

    Children under 6 months: ask a doctor

​Other information

Protect the product in this container from excessive heat and direct sun.

​Inactive ingredients

Water/Aqua, Caprylic/Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes, Glycerin, Polyglyceryl-3 Polyricinoleate, Silica, Glyceryl Caprylate, Lecithin, Rose (Rosa Damascena) Flower Extract, Algae, Aloe (Aloe Barbadensis) Leaf Juice, Isostearic Acid, Polyhydroxystearic Acid, Sunflower (Helianthus Annuus) Seed Oil, Sweet Iris (Iris Pallida) Leaf Cell Extract, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Coco-Caprylate/Caprate, Kukui (Aleurites Moluccanus) Seed Oil, Pumpkin (Cucurbita Pepo) Seed Oil, Squalane, Xanthan Gum, Tamanu (Calophyllum Inophylum) Seed Oil, Pomegranate (Punica Granatum) Extract, Chaparral (Larrea Tridentata) Extract, Leuconostoc/Radish Root Ferment Filtrate, Bisabolol, Tocopherol, Sodium Hyaluronate, Citric Acid

​Package Labeling:

General Label
(click image for full-size original)
Inactive Ingredients
(click image for full-size original)
Jar Label
(click image for full-size original)
Outer Label Details 1
(click image for full-size original)
Outer Label Details 2
(click image for full-size original)

Package Labeling: 70608-001-03

Label --  Kypris Heliotropic 68ml_Page_1
(click image for full-size original)
Label --  Kypris Heliotropic 68ml_Page_2
(click image for full-size original)
Label --  Kypris Heliotropic 68ml_Page_3
(click image for full-size original)
Label --  Kypris Heliotropic 68ml_Page_4
(click image for full-size original)

KYPRIS POT OF SHADE HELIOTROPIC BROAD SPECTRUM SPF 30 SUNSCREEN AND PRIMER
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70608-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
ISOAMYL LAURATE
COCONUT ALKANES
GLYCERIN
SILICON DIOXIDE
GLYCERYL CAPRYLATE
ROSA X DAMASCENA FLOWER
ALOE VERA LEAF
ISOSTEARIC ACID
SUNFLOWER OIL
SODIUM CHLORIDE
COCO-CAPRYLATE/CAPRATE
KUKUI NUT
PUMPKIN SEED OIL
SQUALANE
XANTHAN GUM
TAMANU OIL
POMEGRANATE
LEVOMENOL
TOCOPHEROL
HYALURONATE SODIUM
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70608-001-01 1 JAR in 1 CARTON contains a JAR
1 27 mL in 1 JAR This package is contained within the CARTON (70608-001-01)
2 NDC:70608-001-02 1 JAR in 1 CARTON contains a JAR
2 2.5 mL in 1 JAR This package is contained within the CARTON (70608-001-02)
3 NDC:70608-001-03 1 JAR in 1 CARTON contains a JAR
3 68 mL in 1 JAR This package is contained within the CARTON (70608-001-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/25/2016
Labeler — Kypris Beauty LLC (842161015)

Revised: 12/2019 Kypris Beauty LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.