SPL v6
SPL
SPL Set ID 4f05e474-3211-50f5-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (30 mg)
Inactive Ingredients
Squalene Tomato Ectoine Lactic Acid Coco-caprylate Carrageenan Xanthan Gum Sodium Polymetaphosphate Sodium Stearoyl Glutamate Medium-chain Triglycerides Polyhydroxystearic Acid (2300 Mw) Cetostearyl Alcohol Cetearyl Olivate Pentylene Glycol Glycerin Polygonum Aviculare Top Cardiospermum Halicacabum Seed Water Karum Seed Oil Tocopherol Sorbitan Olivate Jojoba Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-06-01

Description

Zinc oxide 3.0%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • Retains SPF after 40 minutes of activity in the water or sweating
Dosage and Administration
  • For sunscreen use
  • Apply generously and evenly 15 minutes before sun exposure to all skin exposed to the sun
  • Reapply
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures. Do not remain in the sun for too long, even if you are using a sunscreen product. Even with UV light protection, direct sunlight at noontime is to be avoided. If not enough of the product is used, the sun protection provided is significantly reduced. Avoid excessive sunbathing. Do not expose infants and small children to direct sunlight. 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 value 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
  • Ask a doctor before use on children under six month of age
Description

Zinc oxide 3.0%

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

coco caprylate, pongamia glabra seed oil, tocopherol, capric caprylic triglyceride, polyhydroxystearic acid, cetearyl alcohol, cetearyl olivate, sorbitan olivate, water, pentylene glycol nat., carrageenan, xanthan gum, sodium polyphosphate, sodium stearoyl glutamate, cardiospermum halicacabum seed extract, glycerin, polygonum aviculare extract, simmondsia chinensis (jojoba) oil, squalene, solanum lycopersicum (tomato) fruit extract, ectoine, lactic acid, parfum (fragrance).

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc oxide 3.0%

Section 60561-8

Do not store above 25°C. protect the product in this container from excessive heat and direct sun


Structured Label Content

Indications and Usage (34067-9)
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • Retains SPF after 40 minutes of activity in the water or sweating
Dosage and Administration (34068-7)
  • For sunscreen use
  • Apply generously and evenly 15 minutes before sun exposure to all skin exposed to the sun
  • Reapply
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures. Do not remain in the sun for too long, even if you are using a sunscreen product. Even with UV light protection, direct sunlight at noontime is to be avoided. If not enough of the product is used, the sun protection provided is significantly reduced. Avoid excessive sunbathing. Do not expose infants and small children to direct sunlight. 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 value 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
  • Ask a doctor before use on children under six month of age
Warnings and Precautions (34071-1)

For external use only

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)

coco caprylate, pongamia glabra seed oil, tocopherol, capric caprylic triglyceride, polyhydroxystearic acid, cetearyl alcohol, cetearyl olivate, sorbitan olivate, water, pentylene glycol nat., carrageenan, xanthan gum, sodium polyphosphate, sodium stearoyl glutamate, cardiospermum halicacabum seed extract, glycerin, polygonum aviculare extract, simmondsia chinensis (jojoba) oil, squalene, solanum lycopersicum (tomato) fruit extract, ectoine, lactic acid, parfum (fragrance).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc oxide 3.0%

Section 60561-8 (60561-8)

Do not store above 25°C. protect the product in this container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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