BIOLUMIN-C HEAT AGING PROTECTOR SPF50- octocrylene, homosalate, octisalate, and avobenzone lotion

BIOLUMIN-C HEAT AGING PROTECTOR SPF50 by

Drug Labeling and Warnings

BIOLUMIN-C HEAT AGING PROTECTOR SPF50 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, LLC., McKenna. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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), helps decrease 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.

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.

Directions

• After cleansing and toning, apply generously to face 15 minutes prior to sun exposure.
• Reapply at least every two 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 help decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats and sunglasses
• Do not use on infants under 6 months old.

Other information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Propanediol, Butyloctyl Salicylate, Bentonite, Butylene Glycol, Dibutyl Adipate, Polysorbate 80, Physalis Pubescens Fruit Juice, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, VP/Eicosene Copolymer, Aminopropyl Ascorbyl Phosphate, Hydroxyacetophenone, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Oil, Verbascum Thapsus Extract, Citrus Nobilis (Mandarin Orange) Peel Oil, Ricinus Communis (Castor) Seed Oil, Daucus Carota Sativa (Carrot) Root Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Glycerin, Citrus Aurantifolia (Lime) Oil, Tocopherol, Hydrogenated Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Ascorbyl Methylsilanol Pectinate, Beta-Carotene, Caprylic/Capric Triglyceride, Bisabolol, Gluconolactone, Lecithin, Boron Nitride, Xanthan Gum, Methylpropanediol, Silica, Sodium Stearoyl Glutamate, Potassium Cetyl Phosphate, Tetrahydroxypropyl Ethylenediamine, Trisodium Ethylenediamine Disuccinate, Citric Acid, Sodium Hydroxide, Sodium Acrylates Copolymer, Sodium Benzoate, Potassium Sorbate, Limonene, Citrus Species Peel Extract.

Questions or comments

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

immediately
brightens* +
prevents signs of
heat aging**

biolumin-c
heat aging
protector

SPF
50

high
protection

UVA
UVB
broad spectrum

vitamin c + daily
radiance moisturizer

1.7 US FL OZ / 50 mL ℮

dermalogica

INGREDIENTS AND APPEARANCE

BIOLUMIN-C HEAT AGING PROTECTOR SPF50 
octocrylene, homosalate, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-371
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	7 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
SAFFLOWER OIL (UNII: 65UEH262IS)
Propanediol (UNII: 5965N8W85T)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Bentonite (UNII: A3N5ZCN45C)
Butylene Glycol (UNII: 3XUS85K0RA)
Dibutyl Adipate (UNII: F4K100DXP3)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Physalis Pubescens Fruit Juice (UNII: GM2TDN9DZI)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Boron Nitride (UNII: 2U4T60A6YD)
Aminopropyl Ascorbyl Phosphate (UNII: 290O2PQ83R)
Hydroxyacetophenone (UNII: G1L3HT4CMH)
Glycerin (UNII: PDC6A3C0OX)
EDETOL (UNII: Q4R969U9FR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Allantoin (UNII: 344S277G0Z)
LEVOMENOL (UNII: 24WE03BX2T)
Gluconolactone (UNII: WQ29KQ9POT)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
SOYBEAN OIL (UNII: 241ATL177A)
Tocopherol (UNII: R0ZB2556P8)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
VERBASCUM THAPSUS WHOLE (UNII: C9TD27U172)
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
Methylpropanediol (UNII: N8F53B3R4R)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
Sodium Benzoate (UNII: OJ245FE5EU)
ORANGE (UNII: 5EVU04N5QU)
MANDARIN OIL (UNII: NJO720F72R)
GRAPEFRUIT OIL (UNII: YR377U58W9)
CASTOR OIL (UNII: D5340Y2I9G)
LIME OIL, DISTILLED (UNII: 7937R189CB)
ORANGE PEEL (UNII: TI9T76XD44)
Ascorbyl Methylsilanol Pectinate (UNII: M3PF9237YC)
Potassium Sorbate (UNII: 1VPU26JZZ4)
BETA CAROTENE (UNII: 01YAE03M7J)
CARROT (UNII: L56Z1JK48B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-371-02	1 in 1 CARTON	05/22/2024
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68479-371-01	1 in 1 CARTON	05/22/2024
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68479-371-05	1 in 1 CARTON	05/22/2024
3		5 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 68479-371-04	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	05/22/2024

Labeler - Dermalogica, LLC. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-371)