SUNSCREEN- zinc oxide lotion

SUNSCREEN by

Drug Labeling and Warnings

SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Plaine Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc oxide 18%

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 and evenly 15 minutes before sun exposure

reapply:
    after 40 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-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

aloe vera (Aloe barbadensis) leaf juice, caprylic/capric triglyceride (Fractionated coconut oil), octyl palmitate, sorbitan sesquioleate, beeswax (cera alba), glycerin, glyceryl stearate, shea (Butyrospermum parkii) butter, PEG-30 dipolyhydroxystearate, sunflower (Helianthus annuus) seed oil, jojoba (Simmondsia chinensis) seed oil, castor (Ricinus communis) seed oil, white tea (Camellia sinensis) leaf extract, green tea (Camellia sinensis) leaf extract, mate (Ilex paraguariensis) leaf extract, rosemary (Rosmarinus officinalis) leaf oil, lavender (Lavandula angustifolia) oil, raspberry (Rubus idaeus) seed oil, rose hips (Rosa canina) fruit oil, avocado (Persea gratissima) oil, squalane, kukui nut (Aleurites moluccana) oil, tocopheryl acetate (vitamin E acetate), magnesium sulfate, xanthan gum, fragrance, caprylic acid, lauric acid, propanediol, potassium sorbate

Questions?

+1- 513-248-2017

You may also report serious side effects to this phone number.MON - FRI 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

BROAD SPECTRUM SPF 30

RETURN ME I'M REUSABLE

WATER RESISTANT (40 MINUTES)

VEGAN, WATER RESISTANT, REEF SAFE, BIODEGRADABLE FORMULA, PALM OIL FREE, PARABEN FREE, KID SAFE

Crueltyfree

Thank you for helping stop the spread of single-use plastic.

WWW.PLAINEPRODUCTS.COM

Manufactured for: PLAINE PRODUCTS LLC, Cincinnati, OH 45174

Made in the USA

Packaging

INGREDIENTS AND APPEARANCE

SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73757-411
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SHEA BUTTER (UNII: K49155WL9Y)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
CASTOR OIL (UNII: D5340Y2I9G)
WHITE TEA (UNII: O0M3396E09)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ROSEMARY OIL (UNII: 8LGU7VM393)
LAVENDER OIL (UNII: ZBP1YXW0H8)
RASPBERRY SEED OIL (UNII: 9S8867952A)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
AVOCADO OIL (UNII: 6VNO72PFC1)
SQUALANE (UNII: GW89575KF9)
KUKUI NUT OIL (UNII: TP11QR7B8R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLIC ACID (UNII: OBL58JN025)
LAURIC ACID (UNII: 1160N9NU9U)
PROPANEDIOL (UNII: 5965N8W85T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73757-411-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/27/2020

Labeler - Plaine Products (036831114)