Ava Isa Sun Whip Lip Balm Clear Sunshine

Ava Isa Sun Whip Lip Balm Clear Sunshine
SPL v8
SPL
SPL Set ID a8646ee4-5e6e-6cdd-e053-2a95a90aee77
Route
TOPICAL
Published
Effective Date 2020-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20 g)
Inactive Ingredients
.alpha.-tocopherol, D- Medium-chain Triglycerides Glyceryl Isostearate Polyhydroxystearic Acid (2300 Mw) Shea Butter Morella Cerifera Fruit Wax Sodium Stearoyl Lactylate Candelilla Wax Lauryl Laurate Behenyl Behenate Polyglyceryl-10 Stearate Corn Oil Hydrogenated Palm Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-18

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

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 skin aging caused by the sun
Dosage and Administration

Directions

  • Adults and children over 6 months of age
  • Apply liberally to face and body 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • 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 10am - 2pm
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • Protect this product from excessive heat and direct sun
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

Inactive ingredients

Caprylic/capric triglyceride, Butyrospermum Parkii (Shea) Butter, Myrica Cerifera (Bayberry) Fruit Wax, Vegetable oil, Hydrogenated vegetable oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl laurate, Polyhydroxystearic Acid, Behenyl behenate, Polyglyceryl-10 stearate, Sodium stearoyl lactylate, Glyceryl Isostearate, d-alpha Tocopherol.

Section 51945-4

AVA ISA

Sun Lip

Sun Whip®


Clear Sunshine

melt-on-contact all mineral lip balm

SPF 15 Broad Spectrum

UVA/UVB Protection

made with 20% zinc oxide

10 ml (.33 fl oz)

NPN 80097041

Section 53413-1

Questions?

718-481-2628. Monday-Friday, 9 am - 5 pm

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredient

Zinc Oxide* 20%


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 skin aging caused by the sun
Dosage and Administration (34068-7)

Directions

  • Adults and children over 6 months of age
  • Apply liberally to face and body 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • 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 10am - 2pm
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • Protect this product from excessive heat and direct sun
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)

Inactive ingredients

Caprylic/capric triglyceride, Butyrospermum Parkii (Shea) Butter, Myrica Cerifera (Bayberry) Fruit Wax, Vegetable oil, Hydrogenated vegetable oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl laurate, Polyhydroxystearic Acid, Behenyl behenate, Polyglyceryl-10 stearate, Sodium stearoyl lactylate, Glyceryl Isostearate, d-alpha Tocopherol.

Section 51945-4 (51945-4)

AVA ISA

Sun Lip

Sun Whip®


Clear Sunshine

melt-on-contact all mineral lip balm

SPF 15 Broad Spectrum

UVA/UVB Protection

made with 20% zinc oxide

10 ml (.33 fl oz)

NPN 80097041

Section 53413-1 (53413-1)

Questions?

718-481-2628. Monday-Friday, 9 am - 5 pm

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredient

Zinc Oxide* 20%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)