Coconut Vanilla Body Spray Broad Spectrum Spf 50

Coconut Vanilla Body Spray Broad Spectrum Spf 50
SPL v3
SPL
SPL Set ID fc0f7f01-2ca5-9b72-e053-6394a90aa39a
Route
TOPICAL
Published
Effective Date 2023-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Avobenzone (3 g) Octocrylene (8 g)
Inactive Ingredients
Alcohol Aloe Vera Leaf Diisopropyl Adipate .alpha.-tocopherol Acetate Avocado Oil Butyloctyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-26

Description

Active ingredients Purpose Avobenzone 3.0, Octisalate 5.0% Octocrylene 8.0% Sunscreen


Medication Information

Warnings and Precautions

For external use only

Flammable: Do not use near heat, flame, or while smoking

Do not use

  • on damaged or broken skin

When using this product

  • Keep out of eyes
  • Rinse with water to remove
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
Indications and Usage

Stop use and ask a doctor if

  • rash occurs
Dosage and Administration

Directions:

  • Apply Liberally 15 minutes before sun exposure
  • Hold 4 to 6 inches away from body when spraying
  • Children under 6 months of age: Ask a doctor
  • Do not spray directly on face and avoid breathing mist
  • Spray on hand and and apply to face. Use in a well-ventillated area

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.- 2p.m.

Wear long sleeved shirts, pants, hats and sunglasses

Reapply: After 80 minutes of swimming. Immediately after towel use or at least every 2 hours

Description

Active ingredients Purpose Avobenzone 3.0, Octisalate 5.0% Octocrylene 8.0% Sunscreen

Section 50565-1

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away
Section 51727-6

Inactive ingredients: Alcohol Denat., Acrylates/ Octylacrylamide Copolymer, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Diisopropyl Adipate, Fragrance, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate

Section 51945-4

vertra

50

Coconut Vanilla Body Spray

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

NET WT 5 OZ (142 g)

Section 55105-1

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see D irections) decreases the risk of skin cancer and early skin aging caused by the sun
Section 55106-9

Active ingredients Purpose

Avobenzone 3.0, Octisalate 5.0% Octocrylene 8.0% Sunscreen

Section 60561-8

Protect the product in this container from excessive heat and direct sun

May stain some fabrics


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if

  • rash occurs
Dosage and Administration (34068-7)

Directions:

  • Apply Liberally 15 minutes before sun exposure
  • Hold 4 to 6 inches away from body when spraying
  • Children under 6 months of age: Ask a doctor
  • Do not spray directly on face and avoid breathing mist
  • Spray on hand and and apply to face. Use in a well-ventillated area

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.- 2p.m.

Wear long sleeved shirts, pants, hats and sunglasses

Reapply: After 80 minutes of swimming. Immediately after towel use or at least every 2 hours

Warnings and Precautions (34071-1)

For external use only

Flammable: Do not use near heat, flame, or while smoking

Do not use

  • on damaged or broken skin

When using this product

  • Keep out of eyes
  • Rinse with water to remove
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
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 51727-6 (51727-6)

Inactive ingredients: Alcohol Denat., Acrylates/ Octylacrylamide Copolymer, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Diisopropyl Adipate, Fragrance, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate

Section 51945-4 (51945-4)

vertra

50

Coconut Vanilla Body Spray

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

NET WT 5 OZ (142 g)

Section 55105-1 (55105-1)

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see D irections) decreases the risk of skin cancer and early skin aging caused by the sun
Section 55106-9 (55106-9)

Active ingredients Purpose

Avobenzone 3.0, Octisalate 5.0% Octocrylene 8.0% Sunscreen

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun

May stain some fabrics


Advanced Ingredient Data


Raw Label Data

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