Sunblocz

Sunblocz
SPL v6
SPL
SPL Set ID 36fec1f1-5e8b-5764-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (43.4 g)
Inactive Ingredients
Lavender Oil Rosemary Oil Brown Iron Oxide Candelilla Wax Safflower Oil Yellow Wax Rice Bran Grape Seed Oil Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-06-21 Until 2018-06-12
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Directions

  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply:
  • after 80 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. -2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • Protect the product in this container from excessive heat and direct sun
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients

Grape Seed Oil, Safflower Oil, Beeswax, Candelilla wax, Rice Bran Wax, Green Tea, Iron Oxide, Lavender Essential Oil, Rosemary Essential Oil.

Section 51945-4

Sunblocz

100% NATURAL

ZINC OXIDE SUNSCREEN CREAM

NATURALLY TINTED

BROAD SPECTRUM SPF 50

UVA & UVB

Water Resistant (80 minutes)

Dermatologist Recommended

Clinically Tested

Hypoallergenic

6 FL OZ (177 mL)

Section 53413-1

Questions or comments?

www.olencosmetics.com or call toll free 1-877-494-4313

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredient

Zinc Oxide 24.5%

Structured Label Content

Indications and Usage (34067-9)

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 (34068-7)

Directions

  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply:
  • after 80 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. -2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • Protect the product in this container from excessive heat and direct sun
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients

Grape Seed Oil, Safflower Oil, Beeswax, Candelilla wax, Rice Bran Wax, Green Tea, Iron Oxide, Lavender Essential Oil, Rosemary Essential Oil.

Section 51945-4 (51945-4)

Sunblocz

100% NATURAL

ZINC OXIDE SUNSCREEN CREAM

NATURALLY TINTED

BROAD SPECTRUM SPF 50

UVA & UVB

Water Resistant (80 minutes)

Dermatologist Recommended

Clinically Tested

Hypoallergenic

6 FL OZ (177 mL)

Section 53413-1 (53413-1)

Questions or comments?

www.olencosmetics.com or call toll free 1-877-494-4313

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredient

Zinc Oxide 24.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:07.264703 · Updated: 2026-03-14T23:04:37.184149