Equaline Zinc Oxide Sunscreen Stick Spf 50 Cd2-449-161-3

Equaline Zinc Oxide Sunscreen Stick Spf 50 Cd2-449-161-3
SPL v1
SPL
SPL Set ID 1cc27f99-82f3-7aee-e063-6294a90a6f37
Route
TOPICAL
Published
Effective Date 2023-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (216 mg)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Candelilla Wax Sunflower Oil White Wax Neopentyl Glycol Diethylhexanoate Isostearic Acid Cetyl Alcohol Cocoa Butter Ceresin Caprylyl Glycol Butyloctyl Salicylate Silicon Dioxide Isopropyl Palmitate Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-14

Description

Zinc Oxide 21.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 21.6%

Uses
  • 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
Label

Warnings

For external use only

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

  • children under 6 months of age: Ask a doctor
  • 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

do Not Use

• on damaged or broken skin.

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Zinc Oxide 21.6%

inactive Ingredient(s)

beeswax, butyloctyl salicylate, caprylyl/ capric triglyceride, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, fragrance, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, polyhydroxystearic acid, silica

when Using This Product 

• keep out of eyes. Rinse with water to remove.

stop Use and Ask A Doctor If

• rash occurs.

keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • 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
Label

Purpose

Sunscreen

Warnings

For external use only

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

  • children under 6 months of age: Ask a doctor
  • 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

do Not Use (Do not use)

• on damaged or broken skin.

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Zinc Oxide 21.6%

inactive Ingredient(s) (Inactive Ingredient(s))

beeswax, butyloctyl salicylate, caprylyl/ capric triglyceride, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, fragrance, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, polyhydroxystearic acid, silica

when Using This Product  (When using this product )

• keep out of eyes. Rinse with water to remove.

stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs.

keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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