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NDC 69423-0049-75 Olay Regenerist Regenerating Moisturizer 3; 4; 4.5; 2.6 mg/100mL; mg/100mL; mg/100mL; mg/100mL Details
Olay Regenerist Regenerating Moisturizer 3; 4; 4.5; 2.6 mg/100mL; mg/100mL; mg/100mL; mg/100mL
Olay Regenerist Regenerating Moisturizer is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.
Product Information
| NDC | 69423-0049 |
|---|---|
| Product ID | 69423-049_eab4f928-73da-5164-e053-2a95a90a1589 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Olay Regenerist Regenerating Moisturizer |
| Proprietary Name Suffix | Broad Spectrum SPF 15 |
| Non-Proprietary Name | Avobenzone, Homosalate, Octisalate, and Octocrylene |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 3; 4; 4.5; 2.6 |
| Active Ingredient Units | mg/100mL; mg/100mL; mg/100mL; mg/100mL |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE |
| Labeler Name | The Procter & Gamble Manufacturing Company |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 69423-0049-75 (69423004975)
| NDC Package Code | 69423-049-75 |
|---|---|
| Billing NDC | 69423004975 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (69423-049-75) / 75 mL in 1 BOTTLE, PUMP |
| Marketing Start Date | 2015-01-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 03b9b2b1-6cd4-4854-9d91-7ef5c27c5694 Details
SPL UNCLASSIFIED SECTION
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use water resistant sunscreen if swimming or sweating
-
Sun Protection Measures. 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:
- limit time in sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: ask a doctor
Inactive ingredients
water, glycerin, niacinamide*, polymethylsilsesquioxane, dimethicone, isopropyl isostearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, panthenol**, palmitoyl pentapeptide-4***, tocopheryl acetate^, camellia sinensis leaf extract^^, ascorbic acid^^^, allantoin, PTFE, titanium dioxide, stearyl alcohol, caprylyl glycol, behenyl alcohol, 1,2-hexanediol, phenoxyethanol, cetyl alcohol, dimethiconol, PEG-100 stearate, fragrance, sodium benzoate, cetearyl glucoside, cetearyl alcohol, sodium PEG-7 olive oil carboxylate, BHT, disodium EDTA, stearic acid, palmitic acid
PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| OLAY REGENERIST REGENERATING MOISTURIZER
BROAD SPECTRUM SPF 15
avobenzone, homosalate, octisalate, and octocrylene lotion |
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| Labeler - The Procter & Gamble Manufacturing Company (004238200) |
Revised: 10/2022
Document Id: eab4f928-73da-5164-e053-2a95a90a1589
Set id: 03b9b2b1-6cd4-4854-9d91-7ef5c27c5694
Version: 3
Effective Time: 20221010