SPL v1
SPL
SPL Set ID 4246e9f1-1c51-d888-e063-6394a90abda0
Route
TOPICAL
Published
Effective Date 2025-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Methoxycinnamate (9.993 g) Titanium Dioxide (7.8 g)
Inactive Ingredients
Caramel Centella Asiatica Stearic Acid Butylene Glycol Ci 19140 Aluminum Hexafluorosilicate Nonahydrate C13-14 Isoparaffin Glycerin Polyacrylamide (10000 Mw) Sorbitan Sesquioleate Camellia Sinensis Leaf Propylene Glycol Peg-100 Stearate Fragrance Green Floral Orc2000883 Alumina Polygonum Cuspidatum Root Bht Glycyrrhiza Glabra (licorice) Root Ci 16035 Rosmarinus Officinalis (rosemary) Leaf Oil Ethylhexyl Palmitate Laureth-7 Methylparaben Sodium Chloride Water Phenoxyethanol Matricaria Chamomilla Aka102 Glyceryl Stearate Ci 15985 Scutellaria Baicalensis Root

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-29

Description

Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.


Medication Information

Warnings and Precautions

Warnings

Do not use on damaged or broken skin.

For external use only.

When using this product keep out of eyes.

If product gets into the eyes, rinse with water to remove

Stop use and consult a doctor if rash occurs.

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 aging caused by the sun.

Dosage and Administration

Directions

• Apply generously and evenly to face and neck 15-20 minutes before sun exposure.

• Reapply at least every 2 hours

• Use a water-resistant sunscreen when swimming or sweating.

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging.

To reduce this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- Limiting time in the sun, especially from 10 a.m. - 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: Ask a doctor.

Description

Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

WATER

PROPYLENE GLYCOL

STEARIC ACID

ETHYLHEXYL PALMITATE

GLYCERIN

GLYCERYL STEARATE

PEG-100 STEARATE

PHENOXYETHANOL

CARAMEL

POLYACRYLAMIDE

C13-14 ISOPARAFFIN

SORBITAN SESQUIOLEATE

METHYLPARABEN

LAURETH-7

FRAGRANCE

BUTYLENE GLYCOL

CI 19140

AKA102

L5630XRC87

SODIUM CHLORIDE

ALUMINA

CENTELLA ASIATICA EXTRACT

POLYGONUM CUSPIDATUM ROOT EXTRACT

SCUTELLARIA BAICALENSIS ROOT EXTRACT

BHT

CAMELLIA SINENSIS LEAF EXTRACT

GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT

CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT

CI 16035

CI 15985

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

ETHYLHEXYL METHOXYCINNAMATE ---9.993

TITANIUM DIOXIDE ----7.8


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 aging caused by the sun.

Dosage and Administration (34068-7)

Directions

• Apply generously and evenly to face and neck 15-20 minutes before sun exposure.

• Reapply at least every 2 hours

• Use a water-resistant sunscreen when swimming or sweating.

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging.

To reduce this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- Limiting time in the sun, especially from 10 a.m. - 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: Ask a doctor.

Warnings and Precautions (34071-1)

Warnings

Do not use on damaged or broken skin.

For external use only.

When using this product keep out of eyes.

If product gets into the eyes, rinse with water to remove

Stop use and consult a doctor if rash occurs.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

WATER

PROPYLENE GLYCOL

STEARIC ACID

ETHYLHEXYL PALMITATE

GLYCERIN

GLYCERYL STEARATE

PEG-100 STEARATE

PHENOXYETHANOL

CARAMEL

POLYACRYLAMIDE

C13-14 ISOPARAFFIN

SORBITAN SESQUIOLEATE

METHYLPARABEN

LAURETH-7

FRAGRANCE

BUTYLENE GLYCOL

CI 19140

AKA102

L5630XRC87

SODIUM CHLORIDE

ALUMINA

CENTELLA ASIATICA EXTRACT

POLYGONUM CUSPIDATUM ROOT EXTRACT

SCUTELLARIA BAICALENSIS ROOT EXTRACT

BHT

CAMELLIA SINENSIS LEAF EXTRACT

GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT

CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT

CI 16035

CI 15985

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

ETHYLHEXYL METHOXYCINNAMATE ---9.993

TITANIUM DIOXIDE ----7.8


Advanced Ingredient Data


Raw Label Data

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