Sunscreen

Sunscreen
SPL v4
SPL
SPL Set ID 7d4f820d-e154-428e-89c2-2e26e088ceef
Route
TOPICAL
Published
Effective Date 2013-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (6 mg) Octinoxate (7.5 mg) Octisalate (5 mg) Oxybenzone
Inactive Ingredients
Cetyl Alcohol Povidone K30 Propylene Glycol Propylparaben Methylparaben Diazolidinyl Urea Polyoxyl 40 Stearate Polysorbate 60 Petrolatum Water Sorbitan Monostearate Edetate Sodium Titanium Dioxide Xanthan Gum Polyethylene Glycol 400 Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-20

Description

Drug Facts


Medication Information

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, 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 55105-1
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn
Warnings

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.



For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product

  • keep out of eyes
  • rinse with water to remove

Keep out of reach of children.

if swallowed, conatct a poison control center right away

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
  • protect from excessive heat and direct sun
Active Ingredients

Homosalate (6.0%), Octinoxate (7.5%), Octisalate (5.0%), Oxybenzone (5.0%)

Inactive Ingredients

cetyl alcohol, ganex P-904, germaben II, polyoxyl 40 stearate, polysorbate 60, petrolatum, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

Principal Display Panel – Packet

Sunscreen Lotion

SPF 30

1.5 g. (0.0570 oz.)


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, 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 55105-1 (55105-1)
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn
Warnings

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.



For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product

  • keep out of eyes
  • rinse with water to remove

Keep out of reach of children.

if swallowed, conatct a poison control center right away

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
  • protect from excessive heat and direct sun
Active Ingredients

Homosalate (6.0%), Octinoxate (7.5%), Octisalate (5.0%), Oxybenzone (5.0%)

Inactive Ingredients (Inactive ingredients)

cetyl alcohol, ganex P-904, germaben II, polyoxyl 40 stearate, polysorbate 60, petrolatum, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

Principal Display Panel – Packet (PRINCIPAL DISPLAY PANEL – packet)

Sunscreen Lotion

SPF 30

1.5 g. (0.0570 oz.)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)