INTELLIGENT ELIXIRS TINTED BROAD SPECTRUM SPF 30 - NATURAL- avobenzone, octisalate, octinoxate lotion INTELLIGENT ELIXIRS TINTED BROAD SPECTRUM SPF 30 - GOLDEN- avobenzone, octisalate, octinoxate lotion INTELLIGENT ELIXIRS TINTED BROAD SPECTRUM SPF 30 - TAN- avobenzone, octisalate, octinoxate lotion

Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Tan by

Drug Labeling and Warnings

Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Tan by is a Otc medication manufactured, distributed, or labeled by Intelligent Elixirs, LLC, Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%
Octisalate 5%
Octinoxate 7.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

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 consult with doctor if

rash or irritation develops.

Keep out of reach of children

Directions

Apply 15 minutes before sun exposure and as needed.
Reapply at least every 2 hours.

Use water resistant sunscreen if swimming or sweating.

Consult with doctor before use on children under 6 months.
Sun protection measures.
Spending time in the sun increases risk of skin cancer and early skin aging. To decrease this risk, regularly use a broad spectrum SPF of 15 or higher, including: limit time in sun, especially from 10am-2pm, wear long sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

Water, Zinc Oxide, Sorbitan Sesquioleate, Glyceryl Stearate, Cetearyl Alcohol, Ethylhexyl Palmitate, Glycerin, Polysorbate 20, Caprylic/Capric Triglyceride, Polysorbate 60, Potassium Cetyl Phosphate, Dimethicone, Silica, Phenoxyethanol, Cetearyl Glucoside, Jojoba Esters, Ethylhexylglycerin, Glucose. May contain: Titanium Dioxide CI 77891, Iron Oxide CI 77492, Iron Oxide CI 77491, Iron Oxide CI 77499.

Other Information

Store in cool and dry location and protect from excessive sun and heat. Keep closed when not in use to maintain cleanliness.

Question or Comment?

Call 844-643-7546
Email info@ieskincare.com

Principal Display Panel

i|e

intelligent
elixirs

tinted
SPF 30

No Oxybenzone
No Nano-particles

skin: all
shade: natural / golden / tan

1.72 fl oz / 51 ml

INGREDIENTS AND APPEARANCE

INTELLIGENT ELIXIRS TINTED BROAD SPECTRUM SPF 30 - NATURAL 
avobenzone, octisalate, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84977-0031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GLUCOSE (UNII: 5SL0G7R0OK)
ZINC OXIDE (UNII: SOI2LOH54Z)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SILICA (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) (UNII: 12GIN16K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
IRON OXIDES (UNII: 1K09F3G675)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84977-0031-1	1 in 1 CARTON	12/04/2024
1		51 mL in 1 TUBE; 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	12/04/2024

INTELLIGENT ELIXIRS TINTED BROAD SPECTRUM SPF 30 - GOLDEN 
avobenzone, octisalate, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84977-0032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GLUCOSE (UNII: 5SL0G7R0OK)
ZINC OXIDE (UNII: SOI2LOH54Z)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SILICA (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) (UNII: 12GIN16K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
IRON OXIDES (UNII: 1K09F3G675)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84977-0032-1	1 in 1 CARTON	12/04/2024
1		51 mL in 1 TUBE; 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	12/04/2024

INTELLIGENT ELIXIRS TINTED BROAD SPECTRUM SPF 30 - TAN 
avobenzone, octisalate, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84977-0033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GLUCOSE (UNII: 5SL0G7R0OK)
ZINC OXIDE (UNII: SOI2LOH54Z)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SILICA (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) (UNII: 12GIN16K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
IRON OXIDES (UNII: 1K09F3G675)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84977-0033-1	1 in 1 CARTON	12/04/2024
1		51 mL in 1 TUBE; 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	12/04/2024

Labeler - Intelligent Elixirs, LLC (080523847)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(84977-0031, 84977-0032, 84977-0033)