Back9ine Skincare Pure Invisible Sunscreen Spf 50

Back9ine Skincare Pure Invisible Sunscreen Spf 50
SPL v1
SPL
SPL Set ID 974ede40-cfb5-4612-b168-5d42dd137f63
Route
TOPICAL
Published
Effective Date 2025-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (70 mg) Ethylhexyl Salicylate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Adansonia Digitata Seed Oil Aloe Vera Leaf Arnica Montana Flower Butyloctyl Salicylate Calendula Officinalis Flower Green Tea Leaf Medium-chain Triglycerides Cucumber Daucus Carota Subsp. Sativus Seed Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Sunflower Oil Hippophae Rhamnoides Fruit Oil Isododecane Tocopherol Tridecyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-31

Description

Avobenzone 3% Homosalate 7% Octisalate 5% Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 7% Octisalate 5% Octocrylene 10%

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
Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Children under 6 months of age: Ask a doctor
  • Reapply:

    • after 80 minutes of swimming or sweating

    • immediately after towel drying

    • at least every 2 hours

    • do not spray directly on face. Spray into hands and apply to face

    • use in well ventilated areas
  • S un 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.

Drug Facts

Questions?

Call toll-free +1-800-459-4560

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients

Adansonia Digitata Oil, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Seed Extract, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Hippophae Rhamnoides Fruit Oil, Isododecane, Tocopherol, Tridecyl Salicylate

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 120°.

Stop Use and Ask A Doctor If

if rash or irritation occurs.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Children under 6 months of age: Ask a doctor
  • Reapply:

    • after 80 minutes of swimming or sweating

    • immediately after towel drying

    • at least every 2 hours

    • do not spray directly on face. Spray into hands and apply to face

    • use in well ventilated areas
  • S un 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.

Drug Facts

Questions?

Call toll-free +1-800-459-4560

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients

Adansonia Digitata Oil, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Seed Extract, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Hippophae Rhamnoides Fruit Oil, Isododecane, Tocopherol, Tridecyl Salicylate

When Using This Product (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 120°.

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

if rash or irritation occurs.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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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