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
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: Sun Protection Measures.
- 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 Inactive Ingredients Jar Label Outer Label Details 1 Outer Label Details 2

Package Labeling: 70608-001-03

Label - Kypris Heliotropic 68ml_Page_1

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
COCONUT ALKANES (UNII: 1E5KJY107T)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOSTEARIC ACID (UNII: X33R8U0062)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
KUKUI NUT (UNII: J87WJ3E7VW)
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)
SQUALANE (UNII: GW89575KF9)
XANTHAN GUM (UNII: TTV12P4NEE)
TAMANU OIL (UNII: JT3LVK84A1)
POMEGRANATE (UNII: 56687D1Z4D)
LEVOMENOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70608-001-01	1 in 1 CARTON	05/25/2016
1		27 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC:70608-001-02	1 in 1 CARTON	05/25/2016
2		2.5 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC:70608-001-03	1 in 1 CARTON	01/01/2020
3		68 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/25/2016

Labeler - Kypris Beauty LLC (842161015)

Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen & Primer

​Drug Facts

​Active ingredient

​Purpose

​Uses

​Warnings