Sunscreen

Sunscreen
SPL v1
SPL
SPL Set ID 3312d786-1a83-4bba-8b57-077df75293fd
Route
TOPICAL
Published
Effective Date 2012-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Aloe Chamaemelum Nobile Flower Oil Medium-chain Triglycerides Sunflower Oil Lavender Oil Magnesium Sulfate Olive Oil Polyaminopropyl Biguanide Polyglyceryl-10 Oleate Castor Oil Jojoba Oil Sorbitan Monostearate Tocopherol Water Glyceryl Abietate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-18
Description

Active ingredient ZINC OXIDE 20%

Medication Information

Warnings and Precautions
WARNINGS

  • FOR EXTERNAL USE ONLY
Indications and Usage
  • HELPS PREVENT SUNBURN
Dosage and Administration
Directions

• apply liberally 15 minutes before sun exposure.

• use a water resistant sunscreen if swimming or sweating

• reapply at least every 2 hours

Description

Active ingredient ZINC OXIDE 20%

Section 34081-0
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9
  • AND ASK A DOCTOR IF RASH OCCURS.
Section 50567-7
  • 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: *Aloe barbadensis leaf juice, *anthemis nobilis (chamomile) flower oil, caprylic/capric triglycerides, *helianthus annuus (sunflower) seed oil, hydrogenated methyl abietate, *lavandula angustifolia (lavender) flower oil, magnesium sulfate, *olea europaea (olive) fruit oil, polyaminopropyl biguanide, polyglycerol-10 laurate, ricinus communis (castor) seed oil, *simmondsia chinensis (jojoba) seed oil, sorbitan stearate, tocopherol, water.

Section 51945-4
ERBAORGANICS



SPF30

BROAD SPECTRUM SUNSCREEN



Completely natural water resistant (80 minutes)

sunscreen for children and adults.





Section 55105-1

PURPOSE

SUNSCREEN

Section 55106-9
Active ingredient

ZINC OXIDE 20%

Section 60561-8
  • 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-sleeve shirts, pants, hats, and sunglasses

Structured Label Content

Indications and Usage (34067-9)
  • HELPS PREVENT SUNBURN
Dosage and Administration (34068-7)
Directions

• apply liberally 15 minutes before sun exposure.

• use a water resistant sunscreen if swimming or sweating

• reapply at least every 2 hours

Warnings and Precautions (34071-1)
WARNINGS

  • FOR EXTERNAL USE ONLY
Section 34081-0 (34081-0)
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)
  • AND ASK A DOCTOR IF RASH OCCURS.
Section 50567-7 (50567-7)
  • 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: *Aloe barbadensis leaf juice, *anthemis nobilis (chamomile) flower oil, caprylic/capric triglycerides, *helianthus annuus (sunflower) seed oil, hydrogenated methyl abietate, *lavandula angustifolia (lavender) flower oil, magnesium sulfate, *olea europaea (olive) fruit oil, polyaminopropyl biguanide, polyglycerol-10 laurate, ricinus communis (castor) seed oil, *simmondsia chinensis (jojoba) seed oil, sorbitan stearate, tocopherol, water.

Section 51945-4 (51945-4)
ERBAORGANICS



SPF30

BROAD SPECTRUM SUNSCREEN



Completely natural water resistant (80 minutes)

sunscreen for children and adults.





Section 55105-1 (55105-1)

PURPOSE

SUNSCREEN

Section 55106-9 (55106-9)
Active ingredient

ZINC OXIDE 20%

Section 60561-8 (60561-8)
  • 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-sleeve shirts, pants, hats, and sunglasses

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:25.847561 · Updated: 2026-03-14T22:53:02.283244