Baby Sunscreen

Baby Sunscreen
SPL v4
SPL
SPL Set ID c17dec08-5749-424d-8139-1fc0a10515de
Route
TOPICAL
Published
Effective Date 2011-12-30
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-30

Description

ZINC OXIDE 20%


Medication Information

Warnings and Precautions
Warnings

For external use only
Indications and Usage
Other Information

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

• apply liberally 15 minutes before sun exposure

• reapply:

•     after 80 minutes of swimming or sweating

•     immediately after towel drying

•     at least every 2 hours

Description

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
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 Aloe barbadensis leaf juice, anthemis

nobilis flower oil, caprylic/capric triglycerides, helianthus annuus seed

oil, hydrogenated methyl abietate, lavandula angustifolia flower oil,

magnesium sulfate, olea europaea fruit oil, polyaminopropyl

biguanide, polyglycerol-10 laurate, ricinus communis seed oil,

simmondsia chinensis seed oil, sorbitan stearate, tocopherol, water.

Section 51945-4
SEVENTH GENERATION



FOR THE WEE GENERATION



BABY SUNSCREEN

BROAD SPECTRUM SPF 30



Section 55105-1

SUNSCREEN

Section 55106-9
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 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

Structured Label Content

Indications and Usage (34067-9)
Other Information

• protect the product in this container from excessive heat and direct sun
Dosage and Administration (34068-7)
Directions

• apply liberally 15 minutes before sun exposure

• reapply:

•     after 80 minutes of swimming or sweating

•     immediately after towel drying

•     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)
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 Aloe barbadensis leaf juice, anthemis

nobilis flower oil, caprylic/capric triglycerides, helianthus annuus seed

oil, hydrogenated methyl abietate, lavandula angustifolia flower oil,

magnesium sulfate, olea europaea fruit oil, polyaminopropyl

biguanide, polyglycerol-10 laurate, ricinus communis seed oil,

simmondsia chinensis seed oil, sorbitan stearate, tocopherol, water.

Section 51945-4 (51945-4)
SEVENTH GENERATION



FOR THE WEE GENERATION



BABY SUNSCREEN

BROAD SPECTRUM SPF 30



Section 55105-1 (55105-1)

SUNSCREEN

Section 55106-9 (55106-9)
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 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

Advanced Ingredient Data


Raw Label Data

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