BACK9INE SKINCARE PURE INVISIBLE SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene gel

Back9ine Skincare Pure Invisible Sunscreen SPF 50 by

Drug Labeling and Warnings

Back9ine Skincare Pure Invisible Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Back 9ine Skincare, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

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.

Do not use

on damaged or broken skin.

Stop use and ask a doctor if

if rash or irritation occurs.

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°.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

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
• 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

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

Other Information

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

Questions?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

BACK9INE SKINCARE PURE INVISIBLE SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85536-585
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CUCUMBER (UNII: YY7C30VXJT)
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
ISODODECANE (UNII: A8289P68Y2)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85536-585-00	1 in 1 BOX	01/31/2025
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/31/2025

Labeler - Back 9ine Skincare, LLC (120241434)

Registrant - Pure Source, LLC (080354456)