Label: ALMOST MAKEUP SPF 18- octinoxate, titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 38001-801-01, 38001-801-02 - Packager: ASANUMA CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 17, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Actives ingredients
- Purpose
- Use
- Warnings
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Directions
For sunscreen use:
apply liberally 15 minutes before sun exposure.
reapply at least every two hours.
use a water resistant sunscreen if swimming or sweating
Sun Protection Measure.
Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limited time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses.
children under 6 months of age: ask a doctor -
Inactive ingredients
TALC, DIMETHICONE, NYLON-12, SILICA, SQUALANE, BORON NITRIDE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, CETYL ETHYLHEXANOATE, DIISOSTEARYL MALATE, PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE, METHICONE, GLYCERIN, SODIUM HYALURONATE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PALMITOYL PROLINE, ALUMINA, TOCOPHEROL, PALMITIC ACID, 1,2-HEXANEDIOL, HYDRATED SILICA, ASCORBYL TETRAISOPALMITATE, ALUMINUM HYDROXIDE, TIN OXIDE, SODIUM DEHYDROACETATE, [+/- MICA, IRON OXIDIES (CI 77491), IRON OXIDIES ( CI 77492), IRON OXIDIES (CI 77499), TITANIUM DIOXIDE (CI 77891)] [ILN45192]
- Other information
- Principal display panel
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALMOST MAKEUP SPF 18
octinoxate, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:38001-801 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.23 g in 100 g ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) (ETHYLHEXYL METHOXYCRYLENE - UNII:S3KFG6Q5X8) ETHYLHEXYL METHOXYCRYLENE 2 g in 100 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN) HYALURONATE SODIUM (UNII: YSE9PPT4TH) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PALMITIC ACID (UNII: 2V16EO95H1) METHICONE (20 CST) (UNII: 6777U11MKT) MICA (UNII: V8A1AW0880) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) TOCOPHEROL (UNII: R0ZB2556P8) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48) NYLON-12 (UNII: 446U8J075B) PALMITOYL PROLINE (UNII: I49727TDYF) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) STANNIC OXIDE (UNII: KM7N50LOS6) HYDRATED SILICA (UNII: Y6O7T4G8P9) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) Product Characteristics Color white (Skin color) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:38001-801-02 1 in 1 CARTON 03/01/2018 1 NDC:38001-801-01 1 g in 1 JAR; Type 0: Not a Combination Product 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2018 Labeler - ASANUMA CORPORATION (700717762)
