Label: FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT WHITE TEA AND APRICOT- colloidal oatmeal cream
- NDC Code(s): 69423-564-39
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 6, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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INACTIVE INGREDIENT
Water, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, citrus aurantium bergamia (bergamot) fruit extract, citrus aurantium dulcis (orange) peel extract, citrus grandis (grapefruit) peel extract, prunus armeniaca (apricot) fruit extract, rubus idaeus (raspberry) fruit extract, glycyrrhiza glabra (licorice) root extract, ceramide NP, cananga odorata flower extract, citrus aurantifolia (lime) peel extract, citrus aurantium amara (bitter orange) flower extract, cupressus sempervirens leaf/stem extract, mentha piperita (peppermint) leaf extract, pyrus malus (apple) fruit extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, vanilla planifolia fruit extract.
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 14.0 oz (396.8 g)
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INGREDIENTS AND APPEARANCE
FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT WHITE TEA AND APRICOT
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-564 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength CUPRESSUS SEMPERVIRENS LEAFY TWIG (UNII: 7HB6L93P3U) MENTHA PIPERITA LEAF (UNII: A389O33LX6) APPLE (UNII: B423VGH5S9) SAGE (UNII: 065C5D077J) CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SQUALANE (UNII: GW89575KF9) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) SHEA BUTTER (UNII: K49155WL9Y) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALLANTOIN (UNII: 344S277G0Z) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) ORANGE PEEL (UNII: TI9T76XD44) CERAMIDE NP (UNII: 4370DF050B) BERGAMOT OIL (UNII: 39W1PKE3JI) ROSEMARY OIL (UNII: 8LGU7VM393) VANILLA BEAN (UNII: Q74T35078H) RASPBERRY (UNII: 4N14V5R27W) LIME PEEL (UNII: 544EQK5Q0W) CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83) APRICOT (UNII: 269CJD5GZ9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-564-39 396.8 g in 1 JAR; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 01/01/2023 Labeler - The Procter & Gamble Manufacturing Company (004238200)
