DailyMed - 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

NDC Code(s): 84977-0031-1, 84977-0032-1, 84977-0033-1
Packager: Intelligent Elixirs, LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated December 4, 2024

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Active Ingredients
Avobenzone 3% Octisalate 5% Octinoxate 7.5%

Avobenzone 3%
Octisalate 5%
Octinoxate 7.5%
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Purpose
Sunscreen

Sunscreen
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Uses
Helps prevent sunburn

Helps prevent sunburn
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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 ...

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

Close
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 ...

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.
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Inactive Ingredients
Water, Zinc Oxide, Sorbitan Sesquioleate, Glyceryl Stearate, Cetearyl Alcohol, Ethylhexyl Palmitate, Glycerin, Polysorbate 20, Caprylic/Capric Triglyceride, Polysorbate 60, Potassium Cetyl ...

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

Store in cool and dry location and protect from excessive sun and heat. Keep closed when not in use to maintain cleanliness.
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Question or Comment?
Call 844-643-7546 - Email info@ieskincare.com

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

i|e

intelligent
elixirs

tinted
SPF 30

No Oxybenzone
No Nano-particles

skin: all
shade: natural / golden / tan

1.72 fl oz / 51 ml

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INGREDIENTS AND APPEARANCE

Product Information

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	12/04/2024

Labeler - Intelligent Elixirs, LLC (080523847)

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

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Drug Label Information

Do not use

When using this product

Stop use and consult with doctor if

Keep out of reach of children

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Safety

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	NDC
1	84977-0031-1
2	84977-0032-1
3	84977-0033-1

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Drug Label Information

Do not use

When using this product

Stop use and consult with doctor if

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

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