FDA.reportPublic FDA data

SUNSCREEN

Manufacturer
Plaine Products
Effective date
2021-11-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:29:34

Label at a glance#

ProductSUNSCREEN
Active ingredientZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

• 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 me...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 18%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

+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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73757-41173757-411-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYL PALMITATE2865993309IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SHEA BUTTERK49155WL9YIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
CASTOR OILD5340Y2I9GIACT
WHITE TEAO0M3396E09IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ROSEMARY OIL8LGU7VM393IACT
LAVENDER OILZBP1YXW0H8IACT
RASPBERRY SEED OIL9S8867952AIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
AVOCADO OIL6VNO72PFC1IACT
SQUALANEGW89575KF9IACT
KUKUI NUT OILTP11QR7B8RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLIC ACIDOBL58JN025IACT
LAURIC ACID1160N9NU9UIACT
PROPANEDIOL5965N8W85TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
361f04cb-5cfc-43be-bcc8-c8bf22074d650189b198-8afd-4249-8148-371f3e5e8ace2021-11-02WarningsExact identifier
spl id: 361f04cb-5cfc-43be-bcc8-c8bf22074d65
spl set id: 0189b198-8afd-4249-8148-371f3e5e8ace

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.