PURE PROTECT MINERAL SUNSCREEN STICK SPF50- zinc oxide stick

Pure Protect Mineral Sunscreen Stick SPF50 by

Drug Labeling and Warnings

Pure Protect Mineral Sunscreen Stick SPF50 by is a Otc medication manufactured, distributed, or labeled by Koco Life LLC, ENGLEWOOD LAB, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 23.8%

Purpose

Zinc Oxide 23.8%................Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply (liberally or generously) to face, neck, and body 15 minutes before sun exposure.
• Reapply: At least every 2 hour. Use a water resistant sunscreen if swimming or sweating.
• Sun Protection Measures
• Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher & 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

Helianthus Annuus (Sunflower) Seed Cera/Wax/Cire, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Coco-Caprylate, C12-15 Alkyl Benzoate, Ethyl Macadamiate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecanol, Argania Spinosa Kernel Oil, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Copernicia Cerifera Cera (Copernicia Cerifera (Carnauba) Wax, Cire de Carnauba), Methyl Dihydroabietate, Helianthus Annuus (Sunflower) Seed Oil, Candelilla Cera (Euphorbia Cerifera (Candelilla) Wax, Cire de Candelilla), Tocopherol, Jojoba Esters, Behenyl Behenate, Polyhydroxystearic Acid, C18-38 Alkyl Hydroxystearoyl Stearate, Sorbitan Sesquioleate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Bisabolol, Malic Acid, Citric Acid, Canola Oil (Huile de Colza) CI 77491/77492 (Iron Oxides), Farnesol

Other information

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

Questions/Comments

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

Kopari

Pure Protect

Mineral

Sunscreen

Stick SPF 50+

Pure Protect Ecran

Solaire Mineral

En Stick FPS 50+

Net Wt. 0.7 oz. | Poids Net 20 G

INGREDIENTS AND APPEARANCE

PURE PROTECT MINERAL SUNSCREEN STICK SPF50 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	23.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
CANOLA OIL (UNII: 331KBJ17RK)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
FERROUS OXIDE (UNII: G7036X8B5H)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
FARNESOL (UNII: EB41QIU6JL)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
MALIC ACID (UNII: 817L1N4CKP)
OCTYLDODECANOL (UNII: 461N1O614Y)
SHEA BUTTER (UNII: K49155WL9Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ARGAN OIL (UNII: 4V59G5UW9X)
CANDELILLA WAX (UNII: WL0328HX19)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
ISOSTEARIC ACID (UNII: X33R8U0062)
COCO-CAPRYLATE (UNII: 4828G836N6)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-010-07	20 g in 1 CONTAINER; Type 0: Not a Combination Product	09/23/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/23/2024

Labeler - Koco Life LLC (046650159)

Establishment
Name	Address	ID/FEI	Business Operations
ENGLEWOOD LAB, INC.		172198223	manufacture(84130-010)