Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Natural, Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Golden, Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Tan
Generic: AVOBENZONE, OCTISALATE, OCTINOXATE
Basic Information
Manufacturer
Intelligent Elixirs, LLC
Product Type
HUMAN OTC DRUG
Route of Administration
TOPICAL
FDA Set ID
287a61d8-0056-6211-e063-6394a90aa3da
Purpose
Purpose Sunscreen
Indications & Usage
Uses Helps prevent sunburn
Warnings
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
Rinse with water to remove.
Stop use and consult with doctor if rash or irritation develops.
Keep out of reach of children
Technical Data
{
"spl_product_data_elements": [
"Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Natural Avobenzone, Octisalate, Octinoxate CI 77491 CI 77492 DIMETHICONE CAPRYLIC/CAPRIC TRIGLYCERIDE GLUCOSE GLYCERIN OCTISALATE OCTISALATE ZINC OXIDE ETHYLHEXYL PALMITATE OCTINOXATE OCTINOXATE WATER CETEARYL ALCOHOL POLYSORBATE 20 POTASSIUM CETYL PHOSPHATE SILICA PHENOXYETHANOL CETEARYL GLUCOSIDE HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) ETHYLHEXYLGLYCERIN POLYSORBATE 60 AVOBENZONE AVOBENZONE SORBITAN SESQUIOLEATE TITANIUM DIOXIDE GLYCERYL STEARATE CI 77499 Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Golden Avobenzone, Octisalate, Octinoxate DIMETHICONE CAPRYLIC/CAPRIC TRIGLYCERIDE GLUCOSE OCTISALATE OCTISALATE ZINC OXIDE ETHYLHEXYL PALMITATE OCTINOXATE OCTINOXATE WATER CETEARYL ALCOHOL POLYSORBATE 20 GLYCERIN POTASSIUM CETYL PHOSPHATE SILICA PHENOXYETHANOL CETEARYL GLUCOSIDE HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) ETHYLHEXYLGLYCERIN CI 77492 AVOBENZONE AVOBENZONE SORBITAN SESQUIOLEATE TITANIUM DIOXIDE GLYCERYL STEARATE POLYSORBATE 60 CI 77491 CI 77499 Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Tan Avobenzone, Octisalate, Octinoxate CI 77492 DIMETHICONE CAPRYLIC/CAPRIC TRIGLYCERIDE GLUCOSE OCTISALATE OCTISALATE ZINC OXIDE ETHYLHEXYL PALMITATE OCTINOXATE OCTINOXATE WATER CETEARYL ALCOHOL POLYSORBATE 20 GLYCERIN POTASSIUM CETYL PHOSPHATE SILICA PHENOXYETHANOL CETEARYL GLUCOSIDE HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) ETHYLHEXYLGLYCERIN AVOBENZONE AVOBENZONE SORBITAN SESQUIOLEATE TITANIUM DIOXIDE GLYCERYL STEARATE POLYSORBATE 60 CI 77499 CI 77491"
],
"active_ingredient": [
"Active Ingredients Avobenzone 3% Octisalate 5% Octinoxate 7.5%"
],
"purpose": [
"Purpose Sunscreen"
],
"indications_and_usage": [
"Uses Helps prevent sunburn"
],
"warnings": [
"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"
],
"do_not_use": [
"Do not use on damaged or broken skin"
],
"when_using": [
"When using this product Keep out of eyes. Rinse with water to remove."
],
"stop_use": [
"Stop use and consult with doctor if rash or irritation develops."
],
"keep_out_of_reach_of_children": [
"Keep out of reach of children"
],
"dosage_and_administration": [
"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_ingredient": [
"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_safety_information": [
"Other Information Store in cool and dry location and protect from excessive sun and heat. Keep closed when not in use to maintain cleanliness."
],
"questions": [
"Question or Comment? Call 844-643-7546 Email info@ieskincare.com"
],
"package_label_principal_display_panel": [
"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 Outer Packaging - Unit Carton Outer Packaging - Unit Carton Outer Packaging - Unit Carton"
],
"set_id": "287a61d8-0056-6211-e063-6394a90aa3da",
"id": "46b89221-798f-b226-e063-6394a90ab4be",
"effective_time": "20251224",
"version": "2",
"openfda": {
"application_number": [
"M020"
],
"brand_name": [
"Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Natural",
"Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Golden",
"Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Tan"
],
"generic_name": [
"AVOBENZONE, OCTISALATE, OCTINOXATE"
],
"manufacturer_name": [
"Intelligent Elixirs, LLC"
],
"product_ndc": [
"84977-0031",
"84977-0032",
"84977-0033"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"AVOBENZONE",
"OCTINOXATE",
"OCTISALATE"
],
"spl_id": [
"46b89221-798f-b226-e063-6394a90ab4be"
],
"spl_set_id": [
"287a61d8-0056-6211-e063-6394a90aa3da"
],
"package_ndc": [
"84977-0031-1",
"84977-0032-1",
"84977-0033-1"
],
"is_original_packager": [
true
],
"upc": [
"0854500006136",
"0854500006112",
"0854500006129"
],
"unii": [
"4Y5P7MUD51",
"G63QQF2NOX",
"4X49Y0596W"
]
}
}