78 X 36 Spf 30 Active

78 X 36 Spf 30 Active
SPL v2
SPL
SPL Set ID 96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55
Route
TOPICAL
Published
Effective Date 2023-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.2 g)
Inactive Ingredients
Alcohol C9-12 Alkane Medium-chain Triglycerides Cocoyl Caprylocaprate Ethylhexylglycerin Glycerin Phenoxyethanol Potassium Cetyl Phosphate Water Silicon Dioxide Sodium Chloride Sorbitan Olivate Triheptanoin Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

DRUG FACTS

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

DRUG FACTS

Uses

Helps prevent sunburn

lf used as directed with other sun protection measures (see Directions),decreases the risk of skin cancer and early aging caused by the sun

Section 42229-5

DRUG FACTS

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.
Warnings
  • For external use only.
Directions

Apply liberally 15 minutes before sun exposure. Reapply:

  • *
    Immediately after towel drying
  • *
    At least every 2 hours
Other Information

Protect the product in this container from excessive heat and direct sunlight.

Active Ingredients

Zinc Oxide 20%

Inactive Ingredients

Acetyl Ethylhexyl Polyhydroxystearate, Alcohol, Artemia Extract, C9-12 Alkane, Caprylic/Capric Triglycerides, Coco-Caprylate/Caprate, Ethylhexylglycerin,Fragrance, Glycerin, Isoamyl Laurate, Lecithin, Phenoxyethanol, Polyurethane-100, Potassium Cetyl Phosphate, Purified Water, Silica, Sodium Chloride, Sorbitan Olivate, Triheptanoin, Xanthan Gum.

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 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-sleeve shirts, pants, hats, and sunglasses
  • *
    Children under 6 months: Ask a Doctor
Principal Display Panel 96 G Tube Carton

BROAD SPECTRUM

78 x 36

SPF 30

ACTIVE

PROTECT YOUR SKIN

PROTECT YOUR GAME

SPORTS

SWEAT PROTECTION

80 MINUTES

3.4 OZ

96g


Structured Label Content

Uses (USES)

Helps prevent sunburn

lf used as directed with other sun protection measures (see Directions),decreases the risk of skin cancer and early aging caused by the sun

Section 42229-5 (42229-5)

DRUG FACTS

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.
Purpose

Sunscreen

Warnings (WARNINGS)
  • For external use only.
Directions (DIRECTIONS)

Apply liberally 15 minutes before sun exposure. Reapply:

  • *
    Immediately after towel drying
  • *
    At least every 2 hours
Other Information (OTHER INFORMATION)

Protect the product in this container from excessive heat and direct sunlight.

Active Ingredients

Zinc Oxide 20%

Inactive Ingredients (INACTIVE INGREDIENTS)

Acetyl Ethylhexyl Polyhydroxystearate, Alcohol, Artemia Extract, C9-12 Alkane, Caprylic/Capric Triglycerides, Coco-Caprylate/Caprate, Ethylhexylglycerin,Fragrance, Glycerin, Isoamyl Laurate, Lecithin, Phenoxyethanol, Polyurethane-100, Potassium Cetyl Phosphate, Purified Water, Silica, Sodium Chloride, Sorbitan Olivate, Triheptanoin, Xanthan Gum.

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 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-sleeve shirts, pants, hats, and sunglasses
  • *
    Children under 6 months: Ask a Doctor
Principal Display Panel 96 G Tube Carton (PRINCIPAL DISPLAY PANEL - 96 g Tube Carton)

BROAD SPECTRUM

78 x 36

SPF 30

ACTIVE

PROTECT YOUR SKIN

PROTECT YOUR GAME

SPORTS

SWEAT PROTECTION

80 MINUTES

3.4 OZ

96g


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)