262ef129-9453-2411-e063-6294a90ae223

SPL v2
SPL
SPL Set ID 262ef129-9453-2411-e063-6294a90ae223
Route
topical
Published
Effective Date 2024-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (24 g)
Inactive Ingredients
butyloctyl salicylate glycerin niacinamide sodium chloride sodium phytate green tea leaf aloe vera leaf caprylyl glycol ethylhexylglycerin ascorbyl tetraisopalmitate phenoxyethanol silica sorbitan olivate c13-15 alkane cetyl diglyceryl tris(trimethylsiloxy)silylethyl dimethicone (950 mm2/s) water dimethicone isopropyl myristate propanediol synthetic beeswax pentylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-11-05

Description

Zinc Oxide 24.00%


Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Zinc Oxide 24.00%

Indications and Usage

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 generously and evenly 15 minutes before sun exposure

Not suitable for children

apply to all skin exposed to the sun

Reapply

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Apply using your hands, blending into the top half of your arm, then forearm, upper leg and then lower leg, ensuring you are covering all skin. Use more product if needed.

This product includes a gradual tan, therefore, please wash hands after use as product may stain.

Description

Zinc Oxide 24.00%

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

Aloe Barbadensis Leaf

Ascorbyl Tetraisopalmitate

Butyloctyl Salicylate

C13-15 Alkane

Caprylyl Glycol

Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone

Dimethicone

Ethylhexylglycerin

Glycerin

Green Tea Extract

Isopropyl Myristate

Niacinamide

Pentylene Glycol

Phenoxyethanol

Polyhydroxystearic acid

Propanediol

Silica

Sodium Chloride

Sodium Phytate

Sorbitan Olivate

Synthetic Beeswax

Water

Section 51945-4

Section 53413-1

Call toll free 1-888-942-2887

Section 55105-1

Sunscreen


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Zinc Oxide 24.00%

Indications and Usage (34067-9)

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 generously and evenly 15 minutes before sun exposure

Not suitable for children

apply to all skin exposed to the sun

Reapply

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Apply using your hands, blending into the top half of your arm, then forearm, upper leg and then lower leg, ensuring you are covering all skin. Use more product if needed.

This product includes a gradual tan, therefore, please wash hands after use as product may stain.

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)

Aloe Barbadensis Leaf

Ascorbyl Tetraisopalmitate

Butyloctyl Salicylate

C13-15 Alkane

Caprylyl Glycol

Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone

Dimethicone

Ethylhexylglycerin

Glycerin

Green Tea Extract

Isopropyl Myristate

Niacinamide

Pentylene Glycol

Phenoxyethanol

Polyhydroxystearic acid

Propanediol

Silica

Sodium Chloride

Sodium Phytate

Sorbitan Olivate

Synthetic Beeswax

Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call toll free 1-888-942-2887

Section 55105-1 (55105-1)

Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)